Clinical Research Coordinator III

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

Overview:

POSITION SUMMARY:

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

Responsibilities:

ESSENTIAL FUNCTIONS:

• Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols
• Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls
• 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
• Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe
• Conduct preliminary quality assurance reviews of study data
• Present study status reports related to assigned research projects
• Track and maintain study related information in the data management system within the required timeframe
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Responsible for monitoring the inventory of research related supplies
• 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
• Comply with all safety and infection control standards appropriate to this position

• Data entry, checking data entry of other staff

• Making calls to study subjects, labs and physicians' offices

• Assist with maintaining and monitoring freezers, changing tanks, assisting with tasks related to blood and tissue repositories. (May rarely need to work off hours for freezer maintenance as needed.)

• Occasionally meeting in person with study participants, with most communication by phone or email.  

• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Perform other duties as required.

Qualifications:

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a scientific or health related field, or equivalent experience
• 3-5 years of related experience
• Ability to travel off site locations