Clinical Research Coordinator - Open Rank

University of Massachusetts Medical School•Worcester, MA

27d

About The Position

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.

Requirements

Bachelor's degree in a scientific or health related field, or equivalent experience
0-1 year of related experience
Ability to travel off site locations
Requirements noted for CRC I plus:
1-3 years of related experience
Requirements noted for CRC I plus:
3-5 years of related experience
Requirements noted for CRC I plus:
5-7 years of related experience
Demonstrated knowledge of quality management principles in a scientific or hospital setting

Responsibilities

Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls
Coordinate participant remuneration/compensation per protocol
Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
Document and collect data and/or 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 enrollment and completion of milestones
Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.
Track and maintain study related information in the data management system within the required timeframe
Responsible for monitoring the inventory of research related supplies
Participate in grant preparation, 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
Present study status reports related to assigned research projects
Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
Maintain 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 with established policies, health and safety regulations and requirements, procedures, and department objectives
Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
Must practice discretion and adhere to school and hospital confidentiality at all times
Perform other duties as required.
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 compliance
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) processes
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) processes