Regional CRA - CT
Hartford Metro Area, Connecticut
Therapeutic area is Cardiovascular, Respiratory and Ophthalmology
- Serve as a leader and mentor to other CRAs in all aspects of the CRA role.
- 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. Nominate sites to participate in studies in con- junction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
- Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return
- Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications).
- Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems. 8. Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).