Description
Job Duties:- Responsible for working collaboratively with the Lead Study Clinician, Clinical Operations Study Team Lead, and other members of the Study Team
- Will be an integral study team member and key member of study feasibility team to identify, evaluate and select clinical sites and investigators.
- May be responsible for developing a site back-up plan that can be executed to support agreed timelines for study completion.
- Primary focus will be site communication to ensure site is knowledgeable on protocol requirements, recruitment and retention planning, solution and relationship building during the study start-up phase to optimize completion time for the clinical trial start-up phase and ensure site is ready to screen subjects immediately after initiation occurs.
- Work closely with sites to proactively identify, manage and timely resolve study start-up up challenges, bottlenecks, site concerns.
Experience and Skill Level
- Mid-level
- Prefer 5+ year's experience in clinical trial execution (consider less experience for the right candidate).
- Must have thorough understanding local and international regulations applicable to clinical trials.
- The candidate experience should not solely be operational but rather have experience in alignment with our current Clinician position roles and responsibilities .
- The candidate must have EXCELLENT communication skills and be thoroughly comfortable in speaking with prospective PIs and Study Coordinators.
- Must be proficient in collaborative problem-solving skills (A prior CRA or someone with Study Coordinator experience would be a good fit for this position.)
- Required Educational minimum: BA/BS
- Clinical Trial Safety Reporting
- Good Clinical Practices (GCP)