Regulatory Affairs Coordinator - Urology

Brigham and Women's Hospital, Inc.; Boston (MA); Hybrid; USD 28,000 - 40,000; Full time

Job summary

Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs Coordinator I to support regulatory submissions for clinical trials. The role involves collaboration with IRBs, sponsors, and study teams to ensure compliance and accurate documentation.

Qualification includes a Bachelor's degree and 0–1 year of experience, with a hybrid work arrangement at 20 Shattuck Street, Boston. You will manage regulatory binders, training records, and deadlines to support safe, compliant research

Qualifications

• Bachelor's degree required.
• 0–1 year of experience preferred.
• IRB familiarity beneficial.
• Clinical trial knowledge advantageous.

Responsibilities

• 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.
• Maintain regulatory documentation for assigned studies per requirements.
• Manage adverse events and deviation/violation/exception documentation for enrolled patients.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors.
• Collect, complete, and submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and file monitoring correspondence.
• Track deadlines and milestones for regulatory submissions.
• Collaborate with study teams to gather information for regulatory submissions.
• Maintain personnel documentation (training, licenses, etc.).
• Assist with regulatory study information in systems and regulatory tracking tools.
• Prepare and maintain regulatory binders and ensure readiness for review.
• Assist with personnel additions/removals and update systems accordingly.
• Support submissions of deviations and safety reports under supervision.
• Communicate upcoming deadlines and outstanding documentation.
• Maintain regulatory tracking spreadsheets and databases.
• Assist with close-out activities and record maintenance.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research protocols

Education

Bachelor's Degree in related field

Job description

Site:

The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and experience what it means to be part of Mass General Brigham.

Job Summary

The Regulatory Affairs Coordinator I 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. Will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No

Essential Functions

• 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.
• Maintains regulatory documentation for assigned studies in accordance with institutional requirements, sponsor requirements, federal regulations, and GCP guidelines.
• Manage adverse events and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
• Submit Data and Safety Monitoring Reports.
• 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 file all monitoring visit correspondence.
• Tracks regulatory deadlines and study milestones, including continuing reviews, protocol amendments, personnel changes, training expirations, and other required submissions.
• Works with Clinical Research Coordinators, investigators, and other study team members to collect information and documentation needed for regulatory submissions.
• Maintains current study personnel documentation, including CITI/GCP training, CVs, medical licenses, delegation of authority logs, conflict-of-interest documentation, and other required records.
• Assists with maintaining study information in applicable institutional research systems and regulatory tracking tools.
• Prepares and maintains electronic and/or paper regulatory binders and ensures documents are complete, current, appropriately signed and dated, and readily available for review.
• Assists with processing study personnel additions and removals and ensures corresponding regulatory documentation and systems are updated.
• Supports submission and tracking of protocol deviations, safety reports, reportable events, and other regulatory documentation under the guidance of senior regulatory staff.
• Communicates with study teams regarding upcoming regulatory deadlines and outstanding documentation.
• Maintains accurate regulatory tracking spreadsheets and databases.
• Assists with regulatory study close-out activities and maintenance of required records.
• Other duties as assigned.

Qualifications

Education Bachelor's Degree Related Field of Study required.

Can this role accept experience in lieu of a degree? Yes

Experience 0-1 yrs of experience.

Knowledge, Skills and Abilities

• Careful attention to detail.
• Good organizational skills.
• Ability to follow directions.
• Computer literacy.
• Working knowledge of clinical research protocols.

Additional Job Details (if applicable)

Remote Type Hybrid Work Location 20 Shattuck Street

Scheduled Weekly Hours 40

Employee Type Regular Work Shift Day (United States of America)

Pay Range $20.16 - $29.01/Hourly Grade 5

EEO Statement:

2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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