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Clinical Research Coordinator

Woodland International Research Group


Location:
Little Rock, Arkansas
Date:
04/11/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Woodland International Research Group
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Job Details

Position Purpose/Summary

Responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. Completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and Site Director. Maintains accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Essential Job Functions

General

  • Obtains detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
  • Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
  • Manages studies with the Sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
  • Manages studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
  • Serves as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.
  • Contribute to the SOP review and development as delegated by the Site Director.

Study Management

  • Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
  • Attends the investigator meeting for each assigned protocol, as appropriate.
  • In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRB) and other outside regulatory organizations, as required.
  • Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
  • Review and obtain informed consent from with potential study volunteers
  • Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
  • Maintain organized, accurate and complete study records
  • Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
  • Enter data as appropriate for protocol (paper-electronic data capture)
  • In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
  • Perform study close-out procedures
  • Store study records appropriately

Requirements

Knowledge, Education and Experience

  • High School Diploma or its equivalent; College degree preferred
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Able to communicate with providers, co-workers, sponsors, and others in collaborative and courteous manner.
  • Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
  • Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.

Skills and Abilities

  • Excellent communication skills (interpersonal, written, verbal)
  • Ability to perform overnight business travel
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Working Conditions and Other Information

Equipment and Materials Used

  • Standard office equipment including computer, copier, fax, telephone, etc.

Physical Tasks

  • Sitting and viewing computer screen for long periods of time
  • Extensive repetitive hand/wrist movements (telephone console and computer keyboard)
  • Lifting (up to 30 lbs.)

Environmental Demands and Potential Hazards

  • Exposure to hazards from fluorescent lighting, video screens, computers, copiers, faxes, etc.
  • High levels of stress for long periods of time
  • Environment will range from business office setting to clinical areas such as inpatient unit and clinical screening areas. The position requires contact with biological samples, individuals with potentially infectious diseases and with toxic, harmful, or potentially hazardous compounds, solutions, and medications. Noise level can range from quiet to moderate volume.
  • The position also requires scheduled on-call availability of varying degrees based on demands of specific studies, staff availability, and coordination of schedules.

Job Type: Full-time