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