Clinical Operations Specialist Solstice Neurosciences
THIS JOB HAS EXPIRED Position Summary
Clinical Operations Specialist needed to manage clinical trial responsibilities in a biopharmaceutical company. The position is responsible for oversight of conduct of clinical trials and development activities within the clinical operations department. The candidate should have an excellent understanding of GCP/ICH guidelines. The position requires an individual who works independently and in a team environment and who is experienced in project management and group responsibilities. Position requires leadership, collaboration, and excellent communication with other internal functional areas, outside vendors, and contracted sites.
? Conduct qualification, initiation, interim/routine, and closeout monitoring visits (estimated travel up to 50%; can vary depending on corporate/project needs).
? Review essential documents and file per regulatory guidelines.
? Compile and submit IND submissions to the FDA for new protocol amendments, annual reports, safety updates, etc.
? Coordinate review and finalization of various clinical operations trial-related documents/materials (i.e., protocols/amendments, informed consent forms, instruction manuals/sheets, advertisements, data management/analysis plans, clinical study reports, etc.).
? Schedule and conduct teleconferences/meetings to discuss various clinical operations issues (i.e., project management calls, program development calls, etc.).
? Prepare and review budgets, contracts, purchase orders, etc.
? Work with outside vendors (i.e., data management CROs, drug manufacturers/depots, central labs, etc.) to facilitate project needs.
? Provide regular updates to upper management on status of clinical operations issues/progress.
? Knowledge and experience in daily operations of clinical trials, FDA regulations, and ICH guidelines.
? Excellent written and oral communication skills.
? Strong time management and project management capabilities.
? Ability to problem solve when difficult issues arise.
? Detail-oriented and organized.
? Computer skills, including Microsoft Word, Excel, and PowerPoint.
? BA or BS in life sciences or health sciences field.
? Minimum 3 years? experience in a clinical monitoring/research related position, preferably in a pharmaceutical/ biotechnology company, academic institution, or contract research organization.
? Louisville-based or ability to relocate.
||Louisville, KY |
THIS JOB HAS EXPIRED