Clinical Research Associate
Mass General Brigham
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 Clinical Research Associate will be trained on the institutional and federal regulations governing clinical research.
Job description
Job 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 Clinical Research Associate will be trained on the institutional and federal regulations governing clinical research.
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.
Qualifications
Bachelor's Degree required. Research 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.
Requirements
- Bachelor's Degree required
- Research Experience 1-2 years preferred
- 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
Benefits
- Comprehensive Benefits
- Career Advancement Opportunities
- Differentials
- Premiums
- Bonuses
- Recognition Programs
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.