Overview

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.

Responsibilities

Clinical Research Coordinator I

· 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

· Clinical Research Coordinator II - Duties notes 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 compliance

Qualifications

Clinical Research Coordinator I

· 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

· Clinical Research Coordinator II - Requirements notes for Clinical Research Coordinator I     plus:

· 1-3 years of related experience

Additional Information

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

• Meeting logistics, agendas, minutes, and follow-ups
• Documentation systems (SOPs, manuals of operations)
• Experience using project management tools to plan, track, and report on complex research and administrative workflows, such as Microsoft Teams and Project/Planner