Clinical Research Coordinator - Data, Compliance & Study Ops

University of Massachusetts Medical School; Worcester (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision coverage

401(a) retirement plan

Job summary

University of Massachusetts Medical School is seeking qualified Clinical Research Coordinators at multiple levels to support human subject research under PI supervision. Duties include consent, scheduling visits, data management, regulatory compliance, and collaboration with investigators and sponsors.

Positions span CRC I–Sr CRC with increasing responsibilities in data quality, IRB processes, and study coordination.

Qualifications

• Bachelor's degree in a scientific or health related field or equivalent experience.
• 0-1 year of related experience.
• Ability to travel off site locations.
• 1-3 years of related experience for CRC II.
• 3-5 years of related experience for CRC III.
• 5-7 years of related experience for Sr Clinical Research Coordinator.

Responsibilities

• Obtain consent of research participants in accordance with IRB approved protocols and regulations including HIPAA.
• Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls.
• Maintain regulatory documentation including local or central IRB and study data; provide data/support to study Investigators, sponsors and/or external monitors/auditors.
• Identify issues with protocol compliance and keep PI and manager aware of compliance issues.
• Document and collect data and/or samples for research procedures performed during participant visits.
• Ensure clinicians and/or PI document study activities according to protocol.
• Track and maintain study enrollment and completion milestones.
• Assist with financial/operational aspects of grant and contracts; may review clinical research billing.
• Track and maintain study information in the data management system.
• Assist with grant preparation, manuscript writing, data presentations and IRB processes.
• Provide written summaries from literature searches as resources for the team.
• Present study status reports related to assigned projects.
• Participate in design, development, and documentation of study data and collection tools.
• Maintain adherence to all study protocols and regulatory requirements.
• Comply with safety and infection control standards.

Education

Bachelor's degree in a scientific or health related field

0-1 year of related experience

Job description

University of Massachusetts Medical School is seeking qualified Clinical Research Coordinators at multiple levels to support human subject research under PI supervision. Duties include consent, scheduling visits, data management, regulatory compliance, and collaboration with investigators and sponsors.

Positions span CRC I–Sr CRC with increasing responsibilities in data quality, IRB processes, and study coordination.