Clinical Study Specialist Job

CLINICAL STUDY SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Collegeville, PA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Study processes
- FDA regulations
- Pharmaceutical

WHAT YOU'LL BE DOING:

- Provide operational support for delivery of assigned studies or programs on time and within budget through both internal and external sourcing strategies
- Review required regulatory, financial, and legal documents from study sites for quality and accuracy
- Track receipt of regulatory documents from study sites and submit to appropriate departments for approval of drug shipment
- Interact with sites to resolve regulatory and financial document discrepancies
- Assist in reporting and tracking of study budget spend, including processing study invoices
- Order, assemble, distribute, manage and track inventory of study conduct tools and non-drug clinical supplies
- Set up, obtain, and maintain sponsor regulatory, legal, and financial files per SOP
- Assist in planning and facilitating study meetings (Investigator, CRO, Coordinator); assemble materials for study meetings; and attend meetings as needed to provide support
- Assist in providing paper/electronic documentation to support appendices for Clinical Study Reports
- Maintain study/site information in database systems
- Coordinate mass mailings/faxes to study sites

WHAT YOU NEED TO BRING TO THE TABLE:

- High School Diploma plus two years experience in pharmaceutical industry or health related field
- Knowledge of study processes and procedures, including FDA regulations
- Ability to work effectively within interdisciplinary teams
- Ability to effectively handle competing priorities
- Computer proficiency in a variety of databases and software applications
- Ability to manage projects and assignments with minimal supervision

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAXTERM: CON_W2J2WMIDATL

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SFSF: LS