Clinical Research Coord I

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.

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
• Monitor 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
• Practice discretion and adhere to school and hospital confidentiality at all times
• Perform other duties as required

Qualifications

• Bachelor’s degree in a scientific or health related field, or equivalent experience
• 0-1 year of related experience
• Ability to travel to off-site locations

Work Environment

• Usual office environment, laboratory, medical, surgical, and off-campus study sites