Senior Clinical Research Coordinator, CCI
Mass General Brigham
Summary
The MGB OCR/BWH CCI is seeking a full-time Senior Clinical Research Coordinator (CRC-Senior) to join our multidisciplinary team. This position offers the opportunity to take on a leadership role in advancing innovative supportive care research. The CRC-Senior will oversee program-wide regulatory and operational needs across multiple supportive research studies. In addition to contributing to projects employing qualitative methods, survey data, and clinical trial designs, the CRC-Senior will help develop and implement standard operating procedures, onboard and train junior clinical research coordinators (CRCs), and ensure high-quality study execution and compliance. This position is ideal for candidates with prior research experience who are ready to take on supervisory and program development responsibilities.
Job description
Leadership & Training
- Train, and mentor entry-level CRCs, ensuring adherence to standard operating procedures and best practices.
- Assist CCI leadership with allocating workload and providing ongoing feedback.
Study Coordination
- Support participant eligibility reviews, recruitment, informed consent, and coordination of study visits.
- Support data collection (surveys, interviews, chart reviews) and quality control checks, using REDCap or other programs.
- Initiates and maintains recruitment contact with study participants. Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgment as to the suitability of their participation.
- Working in concert with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies.
- Interacts with patients/subjects with regard to the study, including patient education, procedural instruction, and follow-up. Serves as a liaison between patient and physician, and as a resource for participants and their families.
- Responsible for collection data and maintaining patient information databases for the study. Develops, organizes, and/or maintains the study forms. Responsible for data validation and quality control, data entry into CRFs, if applicable. May be required to input data, and do minimal analysis and run various reports.
- In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.
- Responsible for mailing various study information or packets to study participants.
- Answers phone calls and inquire regarding the study protocol. Refers participants when appropriate to principal and co-investigators.
- Communicates regularly with the PI(s) and sponsors about all aspects of the research trial.
- Ensure that knowledge about regulatory requirements are current by reading and attending local seminars related to policy and regulatory issues (FDA, NIH, IRB, etc.)
- Meet regularly with Manager, and CCI Administration.
- Participate in ongoing training and educational activities with CCI. Responsible for providing support for CCI program development.
- Monitors, maintains, sets up any study equipment.
- Maintains inventory and orders supplies when necessary.
- All other duties, as assigned.
Regulatory & Compliance
- Prepare and maintain Institutional Review Board (IRB) protocol submissions, amendments, continuing reviews, and adverse event reports.
- Ensure compliance with study protocols, Human Subjects and Good Clinical Practice guidelines, and institutional policies.
Program Development
- Assist in developing standard operating procedures and quality assurance systems.
- Contribute to creation of study templates and guidance for protocol design, database management, and grant submissions.
- Coordinates the implementation, both internally and externally, of sponsored clinical research studies.
Requirements
- Bachelor's Degree in related field of study required or Graduate Diploma preferred
- Related post-bachelor's degree research experience 3-5 years required
- Ability to work more independently and as a team member
- High degree of computer literacy and analytical skills
- Ability to identify both technical and non-technical problems and develop solutions
- Ability to interpret acceptability of data results
- Highly proficient data management skills and working knowledge of data management systems
- Able to display initiative to introduce innovations to research study
- Excellent time management, organizational, interpersonal, written, and verbal communication skills
Benefits
- Health Insurance
- Career Advancement Opportunities
- Differentials
- Premiums
- Bonuses
- Recognition Programs
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.