Clinical Research Coordinator
Clinical Research - Cumming, GA

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JOB DESCRIPTION: IMMEDIATE OPENING. Implements and coordinates clinical trials in conjunction with Good Clinical Practice (GCP) and Food & Drug Administration (FDA) regulations. Possess knowledge in clinical research and good organizational skills with the ability to manage multiple responsibilities and activities with close attention to detail.

Principal Duties and Responsibilities:

  • Coordinate protocol implementation for clinical trials, including but not limited to, preparation and submission of regulatory documents, patient recruitment and screening, study enrollment and follow-up
  • Communicate with sponsors, investigators, clinical monitors and colleagues to ensure effective clinical trial implementation and progress
  • Initiates and maintains required clinical and regulatory files
  • Participate in investigator meetings, site initiation, interim monitoring and closeout
  • Administer and /or dispense investigation agents as needed
  • Monitor patients’ study progress to fulfill protocol and sponsor requirements
  • Completes clinical course of study subjects as required per protocol, including, but not limited to, laboratory tests vital signs, ECG’s, PFT’s health status assessment and adverse event monitoring
  • Prepare IRB continuations and closures, temperature and patient enrollment logs
  • Assist Investigators on study related activities, as required and/or as time allows
  • Phlebotomy (HAZMAT certificate)
  • GCP Training
  • Scheduling patients, Electronic data capture
  • May be required for off hours and weekends for study-related activities

Minimum Qualifications:

  • High School diploma and
  • 2-4 years experience as a Clinic Research Coordinator
  • Only those with experience need apply

Compensation: Based on experience