Clinical Research Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

23d

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 position with four levels; candidates are hired at the level commensurate with their experience. The coordinator supports lupus research within the Division of Rheumatology, including the Lupus Nexus registry and biorepository, the CurLi translational study, and industry-sponsored and investigator-initiated clinical trials in systemic lupus erythematosus. The position identifies, screens, and recruits eligible patients; obtains informed consent; coordinates study visits; collects and processes biospecimens; administers questionnaires; abstracts clinical data; and enters information into electronic data capture systems and registry platforms. The coordinator also maintains regulatory files, supports IRB processes, prepares for monitoring visits and audits, tracks study progress, and collaborates with investigators, laboratory staff, sponsors, and the wider study team. Responsibilities and authority vary by rank. Across the levels, duties may include quality assurance reviews of data, oversight or supervision of research support staff, staff training, study documentation and tool development, and contributions to grants, manuscripts, presentations, and protocol feasibility assessments.

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.
For the Senior Clinical Research Coordinator level, demonstrated knowledge of quality management principles in a scientific or hospital setting.

Nice To Haves

Prior clinical research experience.
Familiarity with Good Clinical Practice (GCP) and human-subject protections.
Phlebotomy or specimen-handling experience.

Responsibilities

Obtain and document informed consent in accordance with IRB-approved protocols, applicable regulations, and HIPAA.
Identify, screen, select, recruit, maintain, and, as applicable, terminate study participants; recruit eligible patients from rheumatology clinics.
Schedule, coordinate, and conduct study visits, tests, interviews, and telephone follow-up according to protocol schedules.
Coordinate participant remuneration or compensation as specified by study protocols.
Collect, process, and ship blood, urine, and other biospecimens according to protocols and laboratory manuals; maintain sample logs and chain of custody.
Administer questionnaires, collect patient-reported outcomes, and abstract clinical data from medical records.
Document and collect data and samples from research-related procedures, and ensure clinicians and PIs accurately document study activities.
Enter and maintain study information in data management systems, electronic data capture systems, and registry platforms; resolve queries on time.
Maintain regulatory documentation and files, including local or central IRB materials and study data; support IRB submissions, amendments, continuing reviews, and adverse event reporting.
Identify, monitor, and resolve protocol-compliance issues; inform the PI and manager of compliance concerns.
Track enrollment, study completion milestones, visit metrics, and study status; communicate updates to investigators and sponsors.
Prepare for and participate in sponsor monitoring visits, external reviews, and audits; provide data and support to investigators, sponsors, monitors, and auditors.
Perform preliminary and, at higher ranks, accountable or internal quality assurance reviews of study data; report findings as applicable.
Monitor inventory of research-related supplies.
Support financial and operational aspects of grants and contracts; conduct clinical research billing review within required timeframes when assigned.
Participate in grant preparation, protocol feasibility assessment, manuscript writing, data presentations, and IRB processes.
Conduct literature searches and prepare detailed written summaries for the study team and clinicians/PIs.
Participate in designing, developing, and documenting study data and collection tools, including questionnaires, treatment data, and therapeutic checklists.
Direct or supervise research support staff as assigned; assist with staff selection, training, and supervision according to rank.
Prepare ongoing summary reports from multiple data sources and collaborate with investigators on data presentation, interpretation, manuscripts, and grant proposals.
Ensure day-to-day operation of assigned studies and coordination with investigators, staff, clinicians, sponsors, and other collaborators to meet timelines and goals.
Adhere to study protocols, regulatory requirements, Good Clinical Practice (GCP), human-subject protection practices, institutional policies, safety and infection-control standards, and confidentiality requirements.
Perform other duties as required.