Senior Clinical Research Coordinator - University of Massachusetts Medical School

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS:

• 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.

REQUIRED QUALIFICATIONS:

• 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.