Clinical Research Regulatory Coordinator I

Site: Mass General Brigham Incorporated 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 invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary 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 Qualifications Education Education: Bachelor's Degree Related Field of Study required 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 Remote Work Location 101 Merrimac 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 0100 Mass General Brigham Incorporated 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 View phone number on click.appcast.io. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and to establish a strong talent pipeline. Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence. #J-18808-Ljbffr Mass General Brigham Incorporated