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 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. Duties vary by level. Clinical Research Coordinators I and II perform participant consent and visit coordination, maintain regulatory documentation and study data, support investigators and monitors, track enrollment and study milestones, document research procedures, help manage study supplies and operational matters, and contribute to research materials and processes. Level II adds preliminary quality assurance reviews and responsibility for identifying and resolving protocol-compliance issues. Clinical Research Coordinators III and Senior Clinical Research Coordinators take on additional responsibilities, which may include supporting multiple protocols, directing or supervising research support staff, training staff, assessing protocol feasibility, and contributing to grants, manuscripts, data presentations, and IRB processes. Senior Coordinators also support day-to-day study operations, conduct and report internal clinical data quality reviews, and may oversee staff selection, training, and supervision. All levels must follow study protocols, applicable regulatory requirements, Good Clinical Practice guidelines, human-subject protections, safety and infection-control standards, institutional policies, and confidentiality requirements. Other duties may be assigned.

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 research participant consent in accordance with IRB-approved protocols, applicable regulations, and 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 documentation 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 levels II and above, help identify and resolve issues.
Document and collect data or samples for research procedures performed during participant visits, and ensure clinicians and/or the PI accurately document study activities according to protocol.
Track study enrollment and completion of milestones.
Assist with financial and operational aspects of grants and contracts; conduct clinical research billing review within required timeframes when assigned at the applicable level.
Track and maintain study information in the data management system within required timeframes.
Monitor inventory of research-related supplies.
Participate in grant preparation, manuscript writing, data presentations, and IRB processes, with contributions varying 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 research 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.
Adhere to study protocols, regulatory requirements, applicable federal, local, and institutional guidelines, GCP guidelines, human-subject protection practices, safety and infection-control standards, institutional policies, and confidentiality requirements.
At level II, conduct preliminary quality assurance reviews of study data and contribute to study documentation and data-collection tools.
At level III, assist with recruiting, screening, selecting, maintaining, and terminating study subjects for multiple protocols; ensure regulatory documentation is accurate and complete; direct research support staff activities; assist with staff training; and contribute to protocol feasibility assessment.
At the senior level, conduct and report internal clinical data quality reviews; ensure smooth day-to-day operation of assigned studies and achievement of timelines and goals; prepare summary reports; collaborate on data presentation, interpretation, manuscripts, and grant proposals; and assist with staff selection, training, and supervision.