606 Ofertas de Cra Ii en Argentina
cra ii
Hoy
Trabajo visto
Descripción Del Trabajo
CRA Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies
What You Will Be Doing
- Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
- Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
- Collaborating with investigators and site staff to facilitate smooth study conduct.
- Performing data review and resolution of queries to maintain high-quality clinical data.
- Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 1+ years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
- Strong organizational and communication skills, with attention to detail.
- Oncology experience
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
CRA II
Hoy
Trabajo visto
Descripción Del Trabajo
Description
CRA II - Sponsor dedicated - Argentina Home Based
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job Responsibilities
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
- Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
- Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
- Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
- Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
- Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct
Qualifications:
- Bachelor's degree in a related field or equivalent experience
- Minimum of 2-4 years of experience in clinical research monitoring
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Excellent communication and interpersonal skills
- Ability to work independently and manage multiple priorities
- Proficiency in using clinical trial management systems and other relevant software
Certifications:
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills:
- Attention to detail and strong analytical skills
- Problem-solving abilities and critical thinking
- Ability to work effectively in a team environment
- Strong organizational and time management skills
- Proficiency in Microsoft Office Suite
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus
•Conduct thorough on-site and remote monitoring of clinical research studies
•Develop and implement tools, procedures, and processes to ensure quality monitoring
•Manage defined components of projects or processes within their area of responsibility
•Utilize practical knowledge of a professional area, typically obtained through education combined with experience
•Maintain high standards of clinical practice and ensure the success of clinical trials
CRA II
Hoy
Trabajo visto
Descripción Del Trabajo
Description
CRA II (Multi-sponsor) - Argentina Home Based
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job Responsibilities
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
- Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
- Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
- Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
- Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
- Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct
Qualifications:
- Bachelor's degree in a related field or equivalent experience
- Minimum of 2-4 years of experience in clinical research monitoring
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Excellent communication and interpersonal skills
- Ability to work independently and manage multiple priorities
- Proficiency in using clinical trial management systems and other relevant software
Certifications:
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills:
- Attention to detail and strong analytical skills
- Problem-solving abilities and critical thinking
- Ability to work effectively in a team environment
- Strong organizational and time management skills
- Proficiency in Microsoft Office Suite
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus
•Conduct thorough on-site and remote monitoring of clinical research studies
•Develop and implement tools, procedures, and processes to ensure quality monitoring
•Manage defined components of projects or processes within their area of responsibility
•Utilize practical knowledge of a professional area, typically obtained through education combined with experience
•Maintain high standards of clinical practice and ensure the success of clinical trials
CRA II
Hoy
Trabajo visto
Descripción Del Trabajo
CRA I & CRA II (Argentina)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking
CRAs II & Senior CRAs
to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordinating clinical trials, ensuring compliance with regulations, and collecting and analyzing critical data.
What You Will Be Doing
- Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
- Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
- Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff.
- Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements.
Your Profile
- University degree in medicine, science, or equivalent
- Experience monitoring on site +18 months (CRA II) or +24 months (Senior CRA).
- Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
- Excellent written and verbal communication in English
- Good social skills enabling you to deal with queries in a timely manner
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid drivers license
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
CRA II

Publicado hace 9 días
Trabajo visto
Descripción Del Trabajo
**What you will be doing:**
+ Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.
+ Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
+ Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
+ Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
+ Verifies proper management and accountability of Investigational Product (IP).
+ Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
+ Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries.
+ Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
+ Participates in audit preparation and follow-up activities as needed.
+ Independently performs a variety of onsite and offsite monitoring visit types.
+ Gathers and reviews information for assigned siteand identifies inconsistencies. With limitedguidance from project and functional management, assesses risk and escalatesas appropriate.
+ Assists with non-complex adhoc, short-term assignmentin support of additional studies or departmental initiatives.
+ May serve as preceptor, providing training to less experienced clinical team members.
+ Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure, i.e., registered nurse
+ At least one year of experience supporting clinical trials including **on-site monitoring experience** in CROs or pharma companies.
+ Travel is required 50-80%.
+ All employees must read, write and speak fluent English and host country language
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
CRA II (Argentina)
Hoy
Trabajo visto
Descripción Del Trabajo
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking CRAs II & Senior CRAs to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordinating clinical trials, ensuring compliance with regulations, and collecting and analyzing critical data.
Responsibilities- Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
- Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required
- Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
- Ensure patient safety by ensuring compliance with ICON’s procedures, protocols, and regulatory requirements
- University degree in medicine, science, or equivalent
- Experience monitoring on site +18 months (CRA II) or +24 months (Senior CRA).
- Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
- Excellent written and verbal communication in English
- Good social skills enabling you to deal with queries in a timely manner
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid drivers license
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
#J-18808-LjbffrSr CRA II
Hoy
Trabajo visto
Descripción Del Trabajo
Description
Sr CRA II - Sponsor dedicated - Argentina Home Based
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Job Responsibilities
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including verifying the accuracy and completeness of data collected and ensuring adherence to study protocols
- Develop and implement tools, procedures, and processes to ensure quality monitoring, including creating standardized templates for monitoring reports and checklists for site visits
- Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of clinical trial protocols and providing input on study design and methodology
- Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance and support to junior staff members and overseeing the day-to-day activities of clinical trial sites
- Ensure accurate and timely documentation and reporting of clinical trial data, including maintaining detailed records of site visits and monitoring activities and preparing comprehensive reports for regulatory submissions
- Collaborate with cross-functional teams to support clinical trial activities, including working closely with data management, biostatistics, and regulatory affairs teams to ensure the successful execution of clinical trials
- Identify and resolve issues related to clinical trial conduct and data integrity, including troubleshooting problems with data collection and addressing discrepancies in study records
- Provide training and mentorship to junior staff members, including conducting training sessions on monitoring techniques and best practices and offering ongoing support and guidance to help them develop their skills and expertise
Qualifications
- Bachelor's degree in a related field
- Minimum of 3-5 years of experience in clinical research or a related field
- In-depth knowledge of clinical trial processes and regulations
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
Certifications
- Certified Clinical Research Professional (CCRP) or equivalent certification preferred
Necessary Skills
- Proficiency in clinical trial management systems and software
- Strong organizational and time management skills
- Attention to detail and accuracy
- Ability to manage multiple projects and priorities simultaneously
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Impact and Contribution Roles within Clinical Monitoring/CRA job family at the P22 level have a significant impact on the success of clinical research studies. They ensure that clinical projects are conducted, recorded, and reported in accordance with protocols, company and sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. These roles contribute to the overall quality and integrity of clinical data, protect the confidentiality of subjects/patients, and assess factors that might affect subject/patient safety and clinical data integrity. They also provide recommendations regarding site-specific actions, communicate serious issues to the project team, and develop action plans. Additionally, these roles may assume clinical functional leadership tasks, act as primary liaison with study site personnel, and provide guidance at the site and project level towards audit readiness standards. Core Focus
- Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits
- Evaluate overall performance of site and site staff, provide recommendations regarding site-specific actions, and communicate serious issues to the project team
- Verify the process of obtaining informed consent, protect the confidentiality of subjects/patients, and assess factors affecting subject/patient safety and clinical data integrity
- Conduct Source Document Review, verify clinical data accuracy and completeness, and apply query resolution techniques
- Verify site compliance with electronic data capture requirements and investigational product (IP) inventory, reconciliation, storage, and security
- Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile contents with the Trial Master File (TMF)
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met
- Act as primary liaison with study site personnel, ensure training and compliance with applicable requirements, and provide guidance towards audit readiness standards
- Provide direct supervision, training, and mentorship to junior level CRAs
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Acerca de lo último Cra ii Empleos en Argentina !
CRA II (Argentina)
Publicado hace 22 días
Trabajo visto
Descripción Del Trabajo
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking CRAs II & Senior CRAs to join our diverse and dynamic team at ICON Plc. As a key member of our research department, you will be responsible for overseeing and coordinating clinical trials, ensuring compliance with regulations, and collecting and analyzing critical data.
Responsibilities- Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation
- Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required
- Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
- Ensure patient safety by ensuring compliance with ICON’s procedures, protocols, and regulatory requirements
- University degree in medicine, science, or equivalent
- Experience monitoring on site +18 months (CRA II) or +24 months (Senior CRA).
- Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
- Excellent written and verbal communication in English
- Good social skills enabling you to deal with queries in a timely manner
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid drivers license
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
#J-18808-LjbffrCRA II or Senior CRA
Hoy
Trabajo visto
Descripción Del Trabajo
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate II or Senior to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What You Will Be Doing
- Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
- Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
- Collaborating with investigators and site staff to facilitate smooth study conduct.
- Performing data review and resolution of queries to maintain high-quality clinical data.
- Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 2 years of experience as a Clinical Research Associate.
- In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
- Strong organizational and communication skills, with attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
CRA II or Senior CRA
Hoy
Trabajo visto
Descripción Del Trabajo
CRA II or Senior CRA - Buenos Aires (FSP - Sponsor Dedicated)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Clinical Research Associate II or Senior to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
Performing data review and resolution of queries to maintain high-quality clinical data.
Contributing to the preparation and review of study documentation, including protocols and clinical study reports
Your profile
Bachelor's degree in a scientific or healthcare-related field.
Minimum of 2 years of experience as a Clinical Research Associate.
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
Strong organizational and communication skills, with attention to detail.
Ability to work independently and collaboratively in a fast-paced environment.
- Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.