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Snr Clinical Site Manager

Tampa Metro Area, FL

Post Date: 06/20/2017 Job ID: JN -062017-19356
  • TAMPA or ORLANDO Home-Based Clinical Site Manager - Three to five years of experience as a CRA. Trial Lead CRA experience desirable
  • Therapeutic area: Immunology, Dermatology & Neuroscience
    Bachelor s degree or higher in a scientific or healthcare discipline preferred. Prefers a nursing degree or extensive relevant experience
  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role.
  • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
  • Participate in decisions made at assigned meetings (e.g. site selection, site issue resolution).
  • May interview prospective CRA candidates and assist with performance evaluation and management of CRAs.
  • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification
  • Ensure the site Investigator Folder is up to date and mirrors the TMF.
  • Responsible for collecting regulatory documents from site and filing in the TMF.
  • Prepare and collect study site documents.
  • Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE re- porting, GCP, and possibly the drug mechanism.
  • Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials.

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