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 full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide.