Clinical Research Associate: Hybrid Trials & IRB Oversight

1200 The General Hospital Corporation; Boston (MA); Hybrid; USD 57.767.000 - 83.126.000; Vollzeit

Zusammenfassung

The General Hospital Corporation, part of Mass General Brigham, seeks a Clinical Research Associate to ensure regulatory requirements for clinical trials are met. You will work with clinical teams, IRBs, sponsors, and federal agencies, gaining training on institutional and federal regulations governing clinical research.

Remote Type Hybrid; Work Location 55 Fruit Street. The role requires a Bachelor's in a related field and 1–2 years of research experience, with responsibilities spanning

Qualifikationen

• Bachelor's Degree in a Related Field of Study required.
• Research-Related Experience 1-2 years preferred.
• Attention to detail and strong regulatory knowledge are essential.

Aufgaben

• 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 reflect new risks or protocol updates.
• Manage adverse event and deviation documentation and report to sponsor/IRB.
• Maintain source documentation of IRB communications and trial correspondence.
• Submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and document related communications.

Kenntnisse

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Ausbildung

Bachelor's Degree in a Related Field

Jobbeschreibung

The General Hospital Corporation, part of Mass General Brigham, seeks a Clinical Research Associate to ensure regulatory requirements for clinical trials are met. You will work with clinical teams, IRBs, sponsors, and federal agencies, gaining training on institutional and federal regulations governing clinical research.

Remote Type Hybrid; Work Location 55 Fruit Street. The role requires a Bachelor's in a related field and 1–2 years of research experience, with responsibilities spanning