Regulatory Affairs Coordinator | Hybrid – Clinical Trials

Brigham and Women's Hospital; Massachusetts; Hybrid; USD 29,000 - 40,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Brigham and Women's Hospital in Massachusetts is seeking a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. You will work with IRBs, sponsors, and federal agencies, and receive training on governing regulations.

The role offers hybrid work, a 40-hour week, and on-site duties at 20 Shattuck Street. Candidates may have 0–1 year of experience and a Bachelor's degree in a related field.

Qualifications

• Bachelor's degree in related field required.
• 0-1 year of experience minimum.
• Hybrid remote work option but on-site location at 20 Shattuck Street, Worcester MA (Massachusetts).
• Strong attention to detail and organizational abilities.
• Familiarity with clinical research protocols and regulatory environments.

Responsibilities

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk information or protocol changes.
• Maintain regulatory documentation per institutional, sponsor, and federal requirements.
• Manage adverse events and deviation/violation/exception documentation for enrolled patients.
• Submit Data and Safety Monitoring Reports as required.
• Maintain source documentation with IRB, investigators, and sponsors throughout the trial.
• Track regulatory deadlines and study milestones (continuing reviews, amendments, personnel changes).
• Assist with regulatory submissions and study close-out activities.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research knowledge

Education

Bachelor's degree in related field

Job description

Brigham and Women's Hospital in Massachusetts is seeking a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. You will work with IRBs, sponsors, and federal agencies, and receive training on governing regulations.

The role offers hybrid work, a 40-hour week, and on-site duties at 20 Shattuck Street. Candidates may have 0–1 year of experience and a Bachelor's degree in a related field.