Clinical Study Associate Job

CLINICAL STUDY ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Research Triangle Park, NC area.

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
- Ability to work effectively within interdisciplinary teams
- Ability to effectively handle competing priorities
- Computer proficiency in a variety of databases and software applications
- Knowledge of study processes and procedures, including FDA regulations
- Ability to manage projects and assignments with minimal supervision

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2: SCIENTIFIC

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