Clinical Research Coordinator - Open Rank

at  University of Massachusetts Medical School

POSITION SUMMARY:

Under the direction of the Principal Investigator (PI) or designee, the 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 research protocols related to treatment, ancillary services, and prevention practices.
This is an open-rank posting (there are 4 levels of Clinical Research Coordinator) - candidates will be hired into the level commensurate with their experience.
Responsibilities:

Duties noted above plus:

• Conduct preliminary quality assurance reviews of study data
• Contribute to data presentations and Institutional Review Board (IRB) processes
• Track and maintain study related information in the data management system within the required timeframe
• Contribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
• Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding complianc

Duties noted above plus:

• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Direct the activities of research support staff. Assist with the training of staff
• Develop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processe

Duties noted above plus:

• 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
• Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• 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.
• Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processe