Clinical Study Specialist

Excellent Career Opportunity for a Clinical Studies Specialist in the metro area of Pennsylvania. Our client is a recognized leader and innovator in the Pharmaceutical Functional service provider industry.Company: Smith Hanley Consulting GroupStatus: Full Time, EmployeeLocation: PennsylvaniaJob RESPONSIBILITIES: Description: Provide operational support for delivery of assigned studies or programs on time and within budget through both internal and external sourcing strategies. Responsibilities include: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.Ability to work effectively within interdisciplinary teams. Ability to effectively handle competing priorities. Computer proficiency in a variety of databases and software applications.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 client database systems.Coordinate mass mailings/faxes to study sites.Requirements: Ability to work effectively within interdisciplinary teamsAbility to effectively handle competing prioritiesComputer proficiency in a variety of databases and software applicationsKnowledge of study processes and procedures, including FDA regulationsAbility to manage projectsIf you are interested in growing professionally within an innovative, highly respected organization, we invite you to explore this excellent growth opportunity!!!Please email a MS-Word copy of your resume to [Click here for email] or if you have any further questions please call Chris Nordhorn at 1-800-684-9921 x278Smith Hanley Consulting Group,a division of Smith Hanley, specializes in providing clinical trials staffing to national pharmaceutical companies offering long-term contract services of Statisticians, SAS Programmers, Data Managers, Clinical Research Associates and other clinical specialties. Our professional recruiters are recognized leaders in the industry by placing junior to senior candidates into rewarding positions within leading pharmaceutical companies throughout the United States. For more than twenty years, we have built extensive client relationships. We strive to help our candidates make decisions that are consistent with their professional values, priorities and goals as well as provide our clients with candidates that meet their employment needs. www.shcgpharm.com


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Pharm Group