Job Summary
The Clinical Research Associate/Coordinator I (CRA) plays a crucial role in managing and overseeing various clinical research projects. This position involves maintaining detailed records and facilitating communication with the Institutional Review Board (IRB), investigators, and sponsors. The CRA ensures the integrity and compliance of clinical trials conducted at Brigham, collaborating with a diverse team of professionals including nurses, business analysts, technology specialists, and clinical researchers.
Responsibilities
- Coordinate and monitor clinical research studies to ensure adherence to protocols.
- Maintain accurate documentation of all communications with the IRB, investigators, and sponsors.
- Support investigators in executing clinical trials, ensuring all regulatory requirements are met.
- Assist in the preparation of study materials and necessary reporting documentation.
- Collaborate with team members across various disciplines to facilitate research objectives.
Qualifications
- Experience in clinical research or an educational background in a relevant field.
- Strong written and verbal communication skills for effective collaboration.
- Ability to manage multiple tasks and projects in a fast-paced environment.
- Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
- Proficient in data management and documentation procedures.
