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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.
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)
Hybrid
20 Shattuck Street
40
Regular
Day (United States of America)
Pay Range
$20.16 - $29.01/Hourly
Grade
5
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
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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