Clinical Scientist-Cardiovascular

There is a Clinical Scientist position in the Cardiovascular area in Collegeville, PA at a major pharmaceutical company in the area.

Drafts protocols, formulates requirements for clinical supplies and develops CRFs.

As a Clinical Research Scientist, you will participate in preparation of routine clinical documents (i.e. protocols, CRFs, GMRs, ICFs, etc.). You will prepare complex documents with moderate supervision and routine documents independently as directed by supervisor (AHT, CAP, CDP, IND documents, etc.). You will evaluate and select potential investigative sites with minimal to moderate supervision. You will organize and present complex aspects of protocol design at investigator and internal meetings. You will also conduct initiation/monitoring visits independently, coordinate and monitor activities at clinical/investigational sites with minimal supervision by medical monitors and/or project monitors. You may also participate in training/mentoring new hires. You will oversee and coordinate the collection of and/or collect pre-study documents independently. You will monitor safety with minimal to moderate supervision via any of the following: telephone contacts, study event reports, case report form/safety report reviews, contacts with regional clinical associates (RCA), RCA monitoring trip reports, or direct site visits. You will also participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and may serve as Study Team Leader as well as a member of a broad range of CR&D-related and ad hoc committees as needed. You may represent organizational unit at research-wide meetings and on committees, including Global Clinical Project Teams and Interdepartmental Project Teams. In addition, you will serve as a clinical science resource for the team(s), and for peers and/or subordinates.

Required/Desired Skills:
A BS or equivalent with a minimum of 5 years related experience or a MS degree or equivalent in Life Sciences with a minimum of 4 years related experience is required. You must have good interpersonal skills. You must have the ability to work with and negotiate with colleagues to find solutions to resource/supplies/timeline issues. Must have experience in the following: protocol writing, CRF development, formulating requirements for clinical supplies, and medical data review (not data management).Kelly Services is an Equal Opportunity EmployerContact?Information?:.925 Harvest Drive, Ste 100
Blue Bell?PA?19422