Clinical Research Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

About The Position

Under the direction of the 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 aspects of collecting and managing 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. The position supports the Re-Engineered Discharge for Diabetes Care Transitions (REDDCAT2) team, led by Dr. Suzanne Mitchell. The team studies an intervention combining a social-needs screening tool with an evidence-based patient navigation protocol. The intervention is implemented during hospital care transitions to address unmet needs for people living with diabetes. The coordinator supports recruitment, enrollment, and retention activities. Candidates who can commit to at least one year are preferred.

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, in addition to the Clinical Research Coordinator I requirements.
Clinical Research Coordinator III: 3–5 years of related experience, in addition to the Clinical Research Coordinator I requirements.
Senior Clinical Research Coordinator: 5–7 years of related experience, in addition to the Clinical Research Coordinator I requirements.
Ability to travel to off-site locations.
Senior Clinical Research Coordinator: demonstrated knowledge of quality management principles in a scientific or hospital setting.
Maintain discretion and comply with school and hospital confidentiality requirements.

Nice To Haves

Preference for candidates who can commit to at least one year in the role.

Responsibilities

Obtain research participant consent in accordance with IRB-approved protocols, HIPAA, and applicable regulations.
Identify, schedule, and/or conduct participant study visits, tests, interviews, and telephone follow-up calls.
Coordinate participant remuneration or compensation according to protocol.
Maintain regulatory documentation, including local or central IRB records and study data; provide data and support to investigators, sponsors, and external monitors or auditors.
Identify protocol-compliance issues, resolve them at higher levels as assigned, and keep the PI and manager informed.
Document and collect research data and samples during participant study visits, and ensure clinicians and/or the PI accurately document study activities according to protocol.
Track study enrollment, completion of milestones, and study-related information in the data management system within required timeframes.
Assist with grant and contract financial and operational activities; review clinical research billing within the required timeframe at the senior level.
Monitor inventory of research-related supplies.
Participate in or contribute to grant preparation, protocol feasibility assessment, manuscript writing, data presentations, and IRB processes, with increasing independence by level.
Prepare detailed written summaries from literature searches and related sources for the study team and clinicians or PIs; present study status reports for assigned projects.
Participate in or develop study data documentation and collection tools, such as questionnaires, treatment data, and therapeutic checklists.
Adhere to study protocols, regulatory requirements, federal, local, and institutional guidelines, Good Clinical Practice (GCP), human-subject protections, safety and infection-control standards, applicable policies and procedures, and confidentiality requirements.
At level II, conduct preliminary quality-assurance reviews of study data and contribute to data presentations, IRB processes, and study tool development.
At level III, assist with recruiting, screening, selecting, maintaining, and terminating study subjects across multiple protocols; ensure regulatory documentation is accurate and complete; direct research support staff activities and assist with staff training.
At the senior level, conduct and report internal monitoring of clinical data for quality assurance; ensure smooth day-to-day operation of assigned studies and progress toward timelines and goals; prepare ongoing summary reports; collaborate with investigators on data presentation, interpretation, manuscripts, and grant proposals; and assist with staff selection, training, supervision, and study quality assurance.
Perform other duties as required.
Support recruitment, enrollment, and retention for the REDDCAT2 study.