Senior Clinical Research Coordinator

Company:  University of Massachusetts Medical School
Location: Worcester
Hours: Full Time
Type: Permanent
Job Requirements / Description

Under the general direction of the Principal Investigator (PI) or designee, the Senior Clinical Research Coordinator is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.


Accountable for coordinating and obtaining consent of research participants for minimal risk studies in accordance with the IRB approved protocols and all applicable regulations including HIPAA

Responsible for recruiting, screening, selecting, maintaining, and terminating study subjects for multiple protocols

Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports findings

Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting with investigators, staff members, clinicians, sponsors, etc. to ensure project timelines and goals are met

Contribute independently to the development of preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)

May Supervise the activities of research support staff. Assist with the selection, training, and supervision of staff

Prepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals

Oversee all regulatory documentation, including local or central IRB and study data. Oversee provision of data/support to study Investigators, sponsors and/or external monitors/auditors

Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance

Document and collect data and samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol

Track and maintain study related information in the data management system within the required timeframe

Accountable for quality assurance reviews of study data

Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe.

Present study status reports related to assigned research projects.

Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes

Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs

Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.

Comply with all safety and infection control standards appropriate to this position

Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices

Perform other duties as required.


Bachelor’s degree in a scientific or health related field, or equivalent experience

5-7 years of related experience

Demonstrated knowledge of quality management principles in a scientific or hospital setting

Ability to travel off site locations.

Additional Information:


REDCap, eIRB, and experience with clinical research in acute care settings, like EDs and inpatient units.

Strong need for organizational and planning skills and an eye for detail.

Strong experience with project management, including creating and managing task-plans, timelines, and grant charts, and knowledge of how to use software to help provide cogent tracking and progress reports for projects.

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