Snr Clinical Site Manager
Philadelphia Metro Area, Pennsylvania
- PHILADELPHIA 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.