Support the clinical scientist in tracking and managing study supplies, study documentation, enrollment, safety letters, Data review –create and review data listings, maintaining study files, Follow up with study sites.
· Organizes and maintains project working files and tracks critical documents. Reports and tracks discrepancies to senior manager in a timely manner.
· Collects and reviews study related regulatory and financial documents. Distributes copies to appropriate departments within designated timeline.
· Transmits and reconciles all essential documentation to maintain integrity and completeness of archival files as per Forest policy.
· Tracks and assists with processing of site and vendor payments.
· Collects trial enrollment information and updates study management reports under the guidance of the Clinical Scientist.
· Enhances Organizational Performance
· Supports and corresponds with investigative sites to identify site specific needs (e.g. ordering study drug and other trial related supplies).
· Assists with the preparation and distribution of meeting agendas and minutes
· Actively participates in team meetings and prepares minutes
· Provides input and support in the development and distribution of the site newsletters.
· Supports the Regional Site Managers by providing information and supplies, as requested
· Communicates with local and central IRBs and outside vendors to provide information and resolution for specific requests and study issues
Strong EXCEL skills; Must have experience with various phases of a study; Experience with getting a study up and running; IRB; Study close out; Knowledge and review of regulatory documents.
Associate degree or higher with relevant experience in the health sciences
About Precept Life Sciences:
Precept Life Sciences is a premier professional workforce solutions firm headquartered in Sterling, Virginia. Established in 1999, Precept possesses a proven track record of providing key talent for the dynamic Life Science industry within North America. With over 70 years of combined recruiting experience, our team consists of degreed scientists who quickly comprehend complex technical requirements, enabling us to accurately identify the right talent for you. Precept specializes in supporting the Pharmaceutical, Biotech, Medical Device, CMO/CRO industries within the following skill sets. From single placements to comprehensive workforce solutions projects, Precept is committed to offering the right-sized solution for our customers. Simply put, we strive to be your most valued resourcing partner operating within our core values; Integrity, Excellence, Expertise, Results.