Location: New York, NY
Salary: $65,000 to $95,000
Our client is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. They serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
- Provide support to clinical trial manager(s) for all phases of study conduct (feasibility, start-up, maintenance and close-out) of clinical trials.
- Assist with meeting planning for clinical trial activities including vendor, investigator, consultants, safety boards, data monitoring committees, and other external clients.
- Assist in execution of Clinical Trial Communication plan, including coordination of site teleconferences, blast communication, newsletters.
- Attend study team meetings and prepare and distribute study team agendas and minutes as needed.
- Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.).
- Assist managers in tracking contracts, invoices and payments with SMOs, CROs, consultants, vendors and investigators, as appropriate.
- Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
- Provide regulatory agency inspection support by formatting, proofreading documents and contributing to the review of the Trial Master File.
- Assist clinical trial manager(s) with preparation, handling and distribution of Clinical trial supplies and maintenance of tracking information.
- Track in house training of CRO’s SOPs
- Preparation and organization of PowerPoint presentations.
- Preparation and maintenance of investigator information tracker for clinical trial operations.
- Assist with clinical trial protocol and clinical study report (CSR) review, and support for documentation requirements for CSR appendices.
- Provide support for external publications/presentations.
- Assist with tracking of site approvals and denials of study participations.
- Bachelor’s Degree.
- Minimum 3-5 years of experience in related area.
- Excellent planning, coordination, and time management skills to meet deadlines required.
- Demonstrated organization skills and attention to detail.
- Proficient computer skills (e.g. Microsoft Word, Excel, and PowerPoint) required.
- Ability to work independently and with a team.