Clinical Research Coordinator I - Entry-Level Research

University of Massachusetts Medical School; Worcester (MA); On-site; USD 52,000 - 64,000; Full time

Job summary

UMass Chan Medical School is seeking personnel to support clinical research activities and participant visits at various study sites. The role involves obtaining consent, coordinating visits, managing regulatory documents, and ensuring protocol compliance with IRB and HIPAA requirements.

Responsibilities include data collection, enrollment tracking, grant support, and collaboration with investigators and sponsors. Travel to off-site locations may be required as part of the research team.

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.

Responsibilities

• Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Identify, schedule and/or conduct participant study visits, interviews, and tests
• Maintain all 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. Keep principal investigator and manager aware of any issues regarding compliance
• Document and collect data and/or samples for research related procedures performed during participant study visits.
• Ensure clinicians and/or PI accurately document their study activities according to protocol
• Track and maintain study enrollment and completion of milestones
• Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.
• Track and maintain study related information in the data management system within the required timeframe
• Responsible for monitoring the inventory of research related supplies
• Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Present study status reports related to assigned research projects
• Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.
• Comply with all safety and infection control standards appropriate to this position
• Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Must practice discretion and adhere to school and hospital confidentiality at all times
• Perform other duties as required.

Education

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

Job description

UMass Chan Medical School is seeking personnel to support clinical research activities and participant visits at various study sites. The role involves obtaining consent, coordinating visits, managing regulatory documents, and ensuring protocol compliance with IRB and HIPAA requirements.

Responsibilities include data collection, enrollment tracking, grant support, and collaboration with investigators and sponsors. Travel to off-site locations may be required as part of the research team.