Clinical Research Associate

Mass General Brigham•Boston, MA

2d•Hybrid

About The Position

Works under general supervision to ensure that regulatory requirements for clinical trials are met. The role works with clinical teams, Institutional Review Boards (IRBs), clinical trial sponsors, and federal regulatory agencies. The Clinical Research Associate will be trained on institutional and federal regulations governing clinical research. This position does not involve patient care. The position is hybrid and based at 101 Merrimac Street.

Requirements

Bachelor’s degree required.
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.

Nice To Haves

1–2 years of research experience preferred.

Responsibilities

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 updated protocol requirements during the study.
Manage adverse event and deviation, violation, or exception documentation for 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 regulatory entities.
Participate in monitoring visits and maintain a record of related correspondence.