Clinical Research Coordinator III — Lead Data & Compliance

UMass Med School; Shrewsbury (MA); On-site; USD 58,000 - 70,000; Full time

Job summary

UMass Med School is seeking a Clinical Research Coordinator III to work under the PI, independently handling delegated tasks in complex human subject research including data management and regulatory duties.

Responsibilities include obtaining consent, coordinating visits and tests, ensuring regulatory documentation, supervising staff, contributing to grant activities, and monitoring protocol compliance while upholding GCP and HIPAA standards.

Qualifications

• Bachelor's degree in a scientific or health-related field, or equivalent experience.
• 3–5 years of related experience.
• Ability to travel to off-site locations.

Responsibilities

• Obtain consent of research participants under IRB approved protocols and HIPAA.
• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols.
• Identify, schedule and conduct participant study visits, tests and interviews/follow-ups.
• Ensure regulatory documentation accuracy and provide data/support to investigators, sponsors and monitors.
• Direct the activities of research support staff and assist with training.
• Develop study documentation and data collection tools (e.g., questionnaires, data forms).
• Contribute to grant preparation, protocol feasibility assessment, manuscript writing, data presentations and IRB processes.
• Assist with financial/operational aspects of grant and contracts; oversee billing review.
• Conduct preliminary quality assurance reviews of study data.
• Present study status reports for assigned projects.
• Track and maintain study information in data management systems.
• Provide literature summaries for the study team and clinicians/PI.
• Monitor inventory of research-related supplies.
• Document and collect data/samples during visits; ensure protocol documentation.

Education

Bachelor's degree in a scientific or health related field, or equivalent experience

Job description

UMass Med School is seeking a Clinical Research Coordinator III to work under the PI, independently handling delegated tasks in complex human subject research including data management and regulatory duties.

Responsibilities include obtaining consent, coordinating visits and tests, ensuring regulatory documentation, supervising staff, contributing to grant activities, and monitoring protocol compliance while upholding GCP and HIPAA standards.