Clinical Research Associate
A Clinical Research Associate is responsible for monitoring clinical trial progress, ensuring compliance with regulatory standards, overseeing study sites, and assuring the integrity of data collected.
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Sample Job Descriptions for Clinical Research Associate
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
A Clinical Research Associate (CRA), also known as a clinical monitor, is responsible for the coordination, administration, and management of clinical trials. A junior CRA helps in ensuring that clinical trials are conducted ethically and within regulatory compliance, under the supervision of a senior CRA.
Required Skills
- Knowledge of Good Clinical Practice (GCP) and regulatory compliance.
- Data management and record keeping abilities.
- Strong time management and ability to prioritize tasks.
- Proficiency with MS Office Suite and clinical trial management software.
- Teamwork and problem-solving orientation.
Qualifications
- Bachelors degree in life sciences or related field.
- Understanding of clinical trial processes and regulations.
- Attention to detail with strong organizational skills.
- Clear communication and interpersonal skills.
- Ability to travel as needed to visit clinical sites.
Responsibilities
- Assist with the planning and implementation of clinical trials.
- Coordinate with clinical trial sites to ensure adherence to the study protocol.
- Monitor study sites to ensure compliance with Good Clinical Practice (GCP) guidelines and regulations.
- Collect, organize and manage trial data.
- Maintain detailed records of all study activities.
- Coordinate with ethics committees and regulatory authorities.
- Manage the logistics of trial material.
- Ensure patient safety and report any adverse events or deviations from the study protocol.
Intermediate (2-5 years of experience)
Summary of the Role
The Clinical Research Associate (CRA) will play a vital role in the clinical trial process, responsible for overseeing the administration and progress of clinical trials and ensuring that they comply with regulatory standards and clinical protocols. The ideal candidate will have experience in monitoring clinical trials, ensuring adherence to good clinical practices, and effectively communicating between site coordinators, trial sponsors, and other stakeholders. Attention to detail, strong organizational skills, and the ability to manage multiple tasks simultaneously while working in a dynamic and cross-functional team are essential.
Required Skills
- Excellent verbal and written communication skills.
- Strong organizational skills and attention to detail.
- Ability to multitask and prioritize in a fast-paced environment.
- Effective problem-solving and analytical skills.
- Proficiency in Microsoft Office suite and other clinical trial software.
- Good interpersonal skills and the ability to work in a team environment.
Qualifications
- Bachelor's degree in life sciences or related field.
- Minimum 2 years of experience in clinical research or related field.
- Strong understanding of ICH/GCP guidelines and other regulatory requirements for clinical trials.
- Certification as a Clinical Research Associate (CRA) is highly preferred.
- Familiarity with Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
Responsibilities
- Conduct site visits to monitor clinical trials and ensure compliance with protocols.
- Manage and maintain documentation related to clinical trials, including study files and case report forms.
- Act as the main line of communication between the clinical site and the trial sponsor.
- Ensure that the clinical trial is conducted according to the regulatory authority's guidelines and good clinical practices.
- Review and verify data collected during clinical trials to ensure its accuracy and integrity.
- Assist in the development of study materials, including protocols, case report forms, and informed consent documents.
- Train site staff on study procedures to assure compliance with the study protocol and regulatory requirements.
- Monitor patient safety and report adverse events to appropriate parties.
- Collaborate with the clinical trial team to address any issues or concerns that arise during the study.
- Participate in the preparation of reports and ensure timely submission to regulatory agencies.
Senior (5+ years of experience)
Summary of the Role
Seeking a seasoned Clinical Research Associate (CRA) to oversee clinical trials and ensure compliance with protocol and overall clinical objectives. The ideal candidate will have a strong background in clinical research, including an understanding of Good Clinical Practice (GCP) and regulatory requirements.
Required Skills
- Excellent observational and analytical skills.
- Strong organizational and time management abilities.
- Effective communication and interpersonal skills.
- Ability to handle multiple priorities and work under tight deadlines.
- Proficient in the use of clinical trial management software.
Qualifications
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical research, including monitoring clinical trials.
- Familiarity with GCP, FDA, and ICH regulatory requirements.
- Certification as a CRA from an accredited institution is a plus.
Responsibilities
- Monitor clinical trials to ensure compliance with protocols and regulatory requirements.
- Manage the progress of trial sites by ensuring that all necessary supplies and equipment are available.
- Coordinate with ethics committees and regulatory authorities.
- Ensure data integrity through accurate data collection, processing, and analysis.
- Serve as the primary contact for clinical sites, addressing any issues that may arise.
- Train site staff to ensure proper implementation of study protocols.
- Keep abreast of developments in the field of clinical research and adapt protocols as necessary.
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