Clinical Research Coord I

University of Massachusetts Medical School•Worcester, MA

11d

About The Position

Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator I 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.

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

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, interviews, and tests
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.