Job Summary
The Clinical Research Associate (CRA) plays a pivotal role in the execution of clinical trials, facilitating the journey from research to successful trial completion. This position involves overseeing the progress of clinical studies, ensuring compliance with protocols and regulations, and maintaining the integrity of trial data. The CRA serves as a key liaison between sponsors and clinical sites, ensuring that all operational tasks are carried out effectively and efficiently.
Responsibilities
- Monitor clinical study sites to ensure adherence to the study protocol and regulatory requirements.
- Conduct site initiation, monitoring, and close-out visits in accordance with the study plan.
- Review and verify clinical trial data to maintain data integrity and quality.
- Collaborate with site staff to resolve any issues pertaining to the conduct of the trial.
- Prepare and submit necessary documentation to regulatory authorities and ethics committees as required.
- Perform routine checks of clinical documentation and source data for accuracy and completeness.
- Assist in the training of site personnel on study procedures and regulations.
- Provide regular updates to project teams regarding site performance and clinical study timelines.
Qualifications
- A bachelor’s degree in a life science discipline or related field is required.
- Strong understanding of Good Clinical Practice (GCP) and relevant regulatory requirements.
- Excellent communication and interpersonal skills for effective collaboration with site teams.
- Proficiency in data management and experience with clinical trial software is preferred.
- A meticulous attention to detail and the ability to manage multiple projects simultaneously.
