DUTIES AND RESPONSIBILITIES:
- Implements all aspects outlined in the clinical operational plan including closely tracking study site start up, timelines, enrollment, protocol deviations, regulatory documentation, and trial-related materials such as IP and laboratory sample management.
- Ensure site compliance with the trial protocol, GCP, GMP, and regulatory guidelines.
- Prepare study related documents including initiating and developing clinical trial related SOPs.
- Manage and track established clinical trial budgets.
- Work with Clinical leadership to develop and implement clinical trial contingency plans as needed.
- Communicate regularly with clinical sites and CRO to execute and complete clinical trials and for administrative tracking of study materials.
- Work closely with clinical sites to obtain Institutional Review Board (IRB) approval and any other required approvals needed to execute clinical trials.
- Develop and conduct training for clinical site personnel on the trial protocol.
- Develop process for and track patient enrollment, completion of case report forms, adverse events, and study materials at the clinical sites.
- Represent the Company during the on-site preparation and administration of its cell-based products as necessary.
- Problem-solve issues related to screening, enrollment, and follow up of individual patients.
- Coordinate with the Company’s business development group to execute confidentiality agreements and clinical site contracts.
- Coordinate logistically complex study operations across several vendors and between interacting clinical sites.
- May delegate tasks to clinical operations team members as needed
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in a health-related field required with at least 5 years’ experience in clinical research with some experience as a Senior Clinical Trial Associate or higher.
- Experience in operations of neurology clinical trials, experience in Parkinson Disease is strongly preferred.
- Experience in clinical trials utilizing digital health technologies is strongly preferred.
- Experience with clinical trials of cell-based therapeutics, biologics, and/or implanted medical devices, including clinical site support in surgical suites/operating rooms, is strongly preferred.
JOB SPECIFICATIONS:
- Clinical operations knowledge and cross-functional understanding of clinical trial methodology.
- Working knowledge and understanding of ICH-GCP and regulatory guidelines and their implementation in clinical trials.
- Thorough understanding of HIPPA laws and proper handling of patient Protected Health Information (PHI).
- Exceptional organizational skills with the ability to organize and prioritize numerous tasks and complete them under time constraints.
- Collegial personality with the ability to interact effectively with a broad range of organization levels including study coordinators, physicians, and business professionals.
- Ability to present logical solutions to diverse problems proactively before they have an impact on the study.
- Well-developed oral presentation skills and excellent written communication capabilities.
- Ability to understand and communicate biological principles and processes.
- Ability to effectively thrive in a fast-changing small biotech company environment.
- Working knowledge of MS Word, Excel, and PowerPoint is required.
- The candidate must be able to travel nationally approximately 10% to clinical sites.
