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Study Clinician
Ref No.: 14-00965
Location: Collegeville, Pennsylvania
Start Date / End Date: 10/06/2014 to 10/05/2015
Responsible for working collaboratively with the Lead Study Clinician, Clinical Operations Study Team Lead (COSTL), and other members of the Study Team (e.g. Alliance Partner/ CRO, Regulatory Affairs, Pharm Sci, Contracts and Outsourcing) to implement one or more clinical protocols, with focus on study start-up phase. Key member of site feasibility team to identify, evaluate and select clinical sites and investigators. Will be responsibility for developing a site back-up plan that can be executed to support agreed timelines for study Primary focus will be site communication and relationship building during the study start-up phase to optimize completion time for the clinical trial start-up phase Work closely with sites to proactively identify, manage and timely resolve study start-up up challenges, bottlenecks, site concerns.----- Experience and skill Level - Mid-level - Prefer ~5+ year's experience in clinical trial execution ( would consider less experience for the right candidate). Must have thorough understanding local and international regulations applicable to clinical trials. The focus for this pilot project will be the study start-up phase. The candidate experience should not solely be operational but rather have experience in alignment with our current Non-Physician Study. ---- The candidate must have EXCELLENT communication skills and be thoroughly comfortable in speaking with prospective PIs and Study Coordinators. Must be proficient in collaborative problem-solving skills (A prior CRA or someone with Study Coordinator experience would be a good fit for this position.) Required Educational minimum: BA/BS ----- Some Travel/No Overtime; Preferable Collegeville but other would be considered (e.g. Groton)