Clinical Research Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

20h

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 work includes coordinating 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 will be hired at a 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 is studying an intervention that combines a social needs screening tool with an evidence-based patient navigation protocol. The intervention will be implemented during hospital care transitions to address unmet needs among people living with diabetes. The role supports recruitment, enrollment, and retention activities for REDDCAT2. There is a preference for candidates who can commit to at least one year in the role.

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.

Nice To Haves

Ability to commit to at least one year in the role.

Responsibilities

Obtain informed consent from research participants in accordance with IRB-approved protocols and applicable regulations, including HIPAA.
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 study investigators, sponsors, and external monitors or auditors.
Identify protocol-compliance issues, keep the PI and manager informed, and, at higher levels, help resolve compliance issues.
Document and collect data and/or samples for research procedures performed during participant visits, and ensure clinicians and/or the PI document study activities accurately according to protocol.
Track study enrollment, completion of milestones, and study-related information in data management systems within required timeframes.
Assist with financial and operational aspects of grants and contracts; review clinical research billing within required timeframes where applicable to the level.
Monitor inventory of research-related supplies.
Participate in or contribute to grant preparation, protocol feasibility assessment, manuscript writing, data presentations, and IRB processes, as appropriate to the level.
Prepare written summaries of literature searches and related sources for the study team and clinicians or PIs.
Present study status reports for assigned research projects.
Participate in or contribute to the design, development, and documentation of study data 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 protection practices, safety and infection-control standards, confidentiality requirements, and established policies and procedures.
Conduct preliminary quality assurance reviews of study data at the CRC II level; at senior levels, perform or be accountable for quality assurance reviews and report findings.
At higher levels, assist with recruiting, screening, selecting, maintaining, and terminating study subjects across multiple protocols.
At higher levels, direct or supervise research support staff and assist with staff selection, training, and supervision.
At senior level, ensure smooth day-to-day operation of assigned studies and collaborate with investigators on data presentation, interpretation, manuscripts, and grant proposals.
Perform other duties as required.