Job Summary
The Clinical Research Associate (CRA) is responsible for overseeing and monitoring clinical trials to ensure compliance with regulatory requirements and the integrity of the data collected. The CRA plays a pivotal role in managing relationships with clinical sites and ensures that protocols are followed for accurate study results.
Responsibilities
- Monitor and manage clinical trial sites to ensure compliance with Good Clinical Practice (GCP) and relevant regulatory requirements.
- Conduct site visits to prepare for study initiation, monitor ongoing trials, and ensure proper conduct of clinical research activities.
- Collaborate with investigators and site staff to facilitate the smooth operation of clinical studies.
- Review case report forms (CRFs) and other study documentation for accuracy and completeness.
- Ensure adherence to trial protocols and regulatory guidelines while documenting findings and issues.
- Maintain effective communication with the project team to provide updates and resolve any site-related problems.
Qualifications
- Bachelor’s degree in a healthcare-related field or equivalent experience in clinical research.
- Prior experience as a Clinical Research Associate or in a similar role in clinical trials.
- Strong knowledge of clinical research regulations and Good Clinical Practice (GCP).
- Excellent communication and interpersonal skills for effective collaboration.
- Ability to work independently and manage multiple priorities efficiently.
