Mass General Brigham (The McLean Hospital Corporation) is hiring a Clinical Research Regulatory Coordinator I

Site: Mass General Brigham Incorporated Mass General Brigham cultivates a diverse professional ecosystem encompassing medical practitioners, administrative personnel, technology specialists, academic researchers, and systems strategists dedicated to advancing organizational objectives. As a nonprofit institution, we prioritize patient care, scientific exploration, educational initiatives, and community engagement, committed to delivering exceptional healthcare experiences. We champion collaborative excellence and invite talented individuals to become integral members of our transformative healthcare network. Job Summary General Overview Statement: The Clinical Research Regulatory Coordinator I operates under supervisory guidance to ensure comprehensive regulatory compliance for clinical trial protocols. This role involves collaborative interactions with clinical teams, Institutional Review Boards, clinical trial sponsors, and federal regulatory agencies. The coordinator will receive comprehensive training on institutional and federal clinical research regulations, with no direct patient interaction required. Principal Duties and Responsibilities: · Maintain and systematically organize study-specific regulatory documentation · Prepare and submit protocol amendments, continuing reviews, and safety reports to IRB · Revise informed consent documents incorporating emerging risk information and updated protocol requirements · Manage adverse event and deviation/violation/exception documentation for enrolled patients · Report documentation to sponsors and IRB as mandated · Submit Data and Safety Monitoring Reports · Maintain comprehensive source documentation of correspondence · Collect and submit essential regulatory documents to various entities · Participate in monitoring visits and file corresponding documentation · Ensure proper documentation of staff delegation and training · Maintain accurate screening and enrollment logs Skills/Abilities/Competencies Required: · Meticulous attention to detail · Strong organizational capabilities · Exceptional directional comprehension · Effective communication skills · Advanced computer proficiency · Comprehensive understanding of clinical research protocols Qualifications Education: Bachelor's Degree in Related Field Required Experience Substitution: Permissible Licenses/Credentials: None specified Experience Requirements: - Precise detail orientation - Exceptional organizational skills - Ability to follow complex instructions - Computer literacy - Comprehensive clinical research protocol knowledge Additional Job Details Working Conditions: · Remote work environment Remote Type: Remote Work Location: 101 Merrimac Street Scheduled Weekly Hours: 40 Employee Type: Regular Work Shift: Day (United States of America) Pay Range: $19.76 - $28.44/Hourly Grade: 5 Compensation Philosophy: Mass General Brigham values individual contributions, offering comprehensive compensation considering skills, experience, education, and certifications. Beyond competitive base pay, we provide extensive benefits, career advancement opportunities, and recognition programs supporting professional growth. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer committed to diverse, inclusive hiring practices. We evaluate candidates without discrimination, ensuring reasonable accommodations for individuals with disabilities. Competency Framework: Our organizational framework defines leadership effectiveness through ten measurable competencies balancing people-focused and performance-oriented behaviors, facilitating comprehensive talent development and systematic workforce evaluation.