Summary
Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.
Does this position require Patient Care?
No
Essential Functions
-Maintain and organize study-specific regulatory binders.
-Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
-Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
-Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
-Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
-Collect, complete, and submit essential regulatory documents to various regulatory entities.
-Participate in monitoring visits and maintain a record of all correspondence related to these visits.
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Research Related Experience 1-2 years preferred
Knowledge, Skills and Abilities
- Attention to detail.
- Ability to recognize compliance and data integrity issues and respond appropriately.
- Working knowledge of clinical research protocols.
- Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
- Effective interpersonal and communication skills.
Physical Requirements
Clinical Research Associate • Boston, MA, United States
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