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Clinical Research Coordinator

Clinical Research

Full-time-Exempt

Day shift

M-F


 

CLINICAL RESEARCH COORDINATOR

General Job Description

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical research Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works with the PI, sponsor, Contract Research Organization (CRO) and many other clinical departments throughout Central Maine Medical Center (CMMC) to conduct all study related activities.

Administrative Duties

·         Coordinates with Principal Investigator, clinical research department, and CMMC administration to help ensure that clinical research and related activities are performed in accordance with federal and state regulations and CMMC policies and procedures.

·         Assists the Principal Investigator in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits and execution of the research plan. Maintains documentation of training.

·         Coordinates and facilitates monitoring and auditing visits. Notifies appropriate CMMC officials of external audits by FDA and sponsors.

Research Duties

·         Assists the Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations, sponsor and CMMC policies and procedures. 

 


Required skills:                

 

  • Basic typing skills
  • Basic computer skills including competence in Microsoft Word and Outlook
  • Knowledge of medical terminology
  • Data management experience including familiarity with electronic health records

 

Preferred skills:               

 

  • Knowledge of research design and analysis
  • Working knowledge of GCPs, HIPAA and CFRs
  • Experience in patient care
  • Previous experience in completing Case Report Forms 

 


*JIUS