Clinical Trial Coordinator
Mass General Brigham
Summary
Responsible for ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to sponsor standards. Working independently and under general supervision, will support one or more clinical trials and will be responsible for assigned administrative day-to-day project activities.
Job description
Job Summary
Responsible for ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to sponsor standards. Working independently and under general supervision, will support one or more clinical trials and will be responsible for assigned administrative day-to-day project activities.
Essential Functions
- Identify and initiate communications with sites to obtain all relevant documents for project/trial.
- Collect and review the site's essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval.
- Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
- Update and maintain internal databases, tracking systems, project plans, and study files.
- Prepare presentation materials for internal and external meetings.
- Draft meeting agendas and minutes.
- Work with Project Manager to support trial processes and distribution of information and reports to monitors.
- Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial.
- Comply with applicable SOPs.
Qualifications
Education: Bachelor's Degree Related Field of Study required. Can this role accept experience in lieu of a degree? No.
Experience: Research Related Experience 1-2 years required or Familiarity with EDC and CTMS systems 2-3 years preferred.
Knowledge, Skills and Abilities
- Excellent Organizational Skills.
- Solid written and verbal communication skills.
- Strong sense of accountability, the ability to work autonomously.
- Ability to communicate effectively in a matrix environment.
- Ability to manage multiple tasks concurrently and to prioritize work appropriately.
Requirements
- Bachelor's Degree in Related Field of Study required
- Research Related Experience 1-2 years required
- Familiarity with EDC and CTMS systems 2-3 years preferred
- Excellent Organizational Skills
- Solid written and verbal communication skills
- Strong sense of accountability, the ability to work autonomously
- Ability to communicate effectively in a matrix environment
- Ability to manage multiple tasks concurrently and to prioritize work appropriately
Benefits
- 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.