Clinical Research Regulatory Coordinator I

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 directions Good communication skills Computer literacy Working knowledge of clinical research protocols Education Bachelor's Degree Related Field of Study required. Physical Requirements Standing Occasionally (3-33%) Walking Occasionally (3-33%) Sitting Constantly (67-100%) Lifting Occasionally (3-33%) 20lbs - 35lbs Carrying Occasionally (3-33%) 20lbs - 35lbs Pushing Rarely (Less than 2%) Pulling Rarely (Less than 2%) Climbing Rarely (Less than 2%) Balancing Occasionally (3-33%) Stooping Occasionally (3-33%) Kneeling Rarely (Less than 2%) Crouching Rarely (Less than 2%) Crawling Rarely (Less than 2%) Reaching Occasionally (3-33%) Gross Manipulation (Handling) Constantly (67-100%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) 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. #J-18808-Ljbffr Mass General Brigham (Enterprise Services)