Mass General Brigham (Enterprise Services)
Clinical Research Regulatory Coordinator I
Mass General Brigham (Enterprise Services), Boston, Massachusetts, us, 02298
General Summary/Overview Statement
The Clinical Research Regulatory Coordinator I (CRRCI) 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 CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Principal Duties and Responsibilities
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
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
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directionsGood communication skills
Computer literacy
Working knowledge of clinical research protocols
Education Bachelor's Degree Related Field of Study required
Experience Related experience may substitute for a degree
Working Conditions Duties will be performed remotely
Equal Opportunity Statement Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
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Principal Duties and Responsibilities
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
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
Ensure appropriate documentation of delegation and training for all study staff members
Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
Careful attention to detail
Good organizational skills
Ability to follow directionsGood communication skills
Computer literacy
Working knowledge of clinical research protocols
Education Bachelor's Degree Related Field of Study required
Experience Related experience may substitute for a degree
Working Conditions Duties will be performed remotely
Equal Opportunity Statement Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
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