Clinical Research Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

About The Position

Under the direction of a Principal Investigator (PI) or designee, the Clinical Research Coordinator independently performs delegated tasks and procedures involving human-subject research. The role coordinates regulatory activities and supports the collection and management of data for research protocols related to treatment, ancillary services, and prevention practices. This is an open-rank posting with four levels; candidates are hired at the level commensurate with their experience. Responsibilities vary by level. All levels support study operations, participant visits and follow-up, consent, regulatory documentation, protocol compliance, study data and materials, and related research activities. Higher levels add quality assurance and monitoring, staff direction or supervision, coordination of multiple studies, and greater independence in protocol feasibility, study documentation, grants, presentations, and manuscripts.

Requirements

Bachelor’s degree in a scientific or health-related field, or equivalent experience.
Clinical Research Coordinator I: 0–1 year of related experience.
Clinical Research Coordinator II: 1–3 years of related experience.
Clinical Research Coordinator III: 3–5 years of related experience.
Senior Clinical Research Coordinator: 5–7 years of related experience.
Ability to travel to off-site locations.
Senior Clinical Research Coordinator: demonstrated knowledge of quality-management principles in a scientific or hospital setting.

Responsibilities

Obtain participant consent in accordance with IRB-approved protocols, applicable regulations, and HIPAA.
Identify, schedule, and/or conduct study visits, tests, interviews, and telephone follow-up calls.
Coordinate participant remuneration or compensation according to the protocol.
Maintain regulatory documentation, including local or central IRB records and study data, and provide information or support to investigators, sponsors, and external monitors or auditors.
Identify protocol-compliance issues, resolve them at applicable levels, and keep the PI and manager informed.
Document and collect research data and/or samples during participant study procedures, and ensure clinicians and/or the PI accurately document study activities according to protocol.
Track study enrollment and milestones, and maintain study information in the data management system within required timeframes.
Assist with financial and operational aspects of grants and contracts; review clinical research billing within required timeframes where assigned.
Monitor inventory of research supplies.
Participate in grant preparation, manuscript writing, data presentations, and IRB processes; contribute to these activities at higher levels.
Prepare detailed written summaries of literature searches and related sources for the study team and clinicians or PIs.
Present study-status reports for assigned projects.
Participate in the design, development, and documentation of study data and collection tools, such as questionnaires, treatment data, and therapeutic checklists; contribute to preliminary designs at higher levels.
Follow study protocols and applicable federal, local, and institutional regulatory requirements, Good Clinical Practice guidelines, and human-subject protection practices.
Comply with safety, infection-control, health and safety, confidentiality, institutional, and departmental policies and requirements.
At level II, conduct preliminary quality-assurance reviews of study data.
At level III, assist with recruiting, screening, selecting, maintaining, and terminating subjects across multiple protocols; ensure regulatory documentation and study data are accurate and complete; direct research support staff activities and assist with staff training; contribute to protocol-feasibility assessment.
At senior level, conduct and report internal clinical-data quality reviews; oversee day-to-day operation of assigned studies and coordinate with investigators, staff, clinicians, and sponsors to meet timelines and goals; prepare ongoing summary reports; collaborate on data presentation, interpretation, manuscripts, and grant proposals; and assist with staff selection, training, and supervision where applicable.
Perform other duties as required.