Description
We're looking for a Clinical Trial Associate, working in Biotechnology/Medical Devices industry in Madison, New Jersey, United States.
Job Description:
- Support study feasibility activities and perform database/web searches for sites as needed.
- Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
- Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.
- Reconcile and transmit all essential documentation to CDIC as per Forest policy.
- Track and assist with processing site/vendor payments. Follow up on any issues as required.
- Collect and track patient enrollment information and update study management reports as necessary.
- Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.
- Assist senior team members with the planning, preparation, and on-site support of investigators meetings.
- Generate reports in various applications to assist the Clinical Scientist to perform clinical data review.
- Assist with ongoing data review and discuss comments with the clinical study team as needed.
- Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
- Provide input and support in the development and distribution of monthly site newsletters.
- Support the Regional Site Managers by providing study related information and supplies, as requested.
- Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.
- Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
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