Description
Responsible for working collaboratively with various departments to implement one or more clinical protocols, with focus on study start-up phase. Will serve as a key member of site feasibility team to identify, evaluate and select clinical sites and investigators. Will be responsible for developing a site back-up plan that can be executed to support agreed timelines for study. Primary focus will be site communication and relationship building during the study start-up phase to optimize completion time for the clinical trial start-up phase. Work closely with sites to proactively identify, manage and timely resolve study start-up challenges, bottlenecks, site concerns.
SKILLS:
- Prefer ~5+ year's experience in clinical trial execution (I would consider less experience for the right candidate).
- Must have thorough understanding local and international regulations applicable to clinical trials. The focus for this pilot project will be the study start-up phase. The candidate experience should not solely be operational but rather have experience in alignment with our current Non-Physician Study.
- The candidate must have EXCELLENT communication skills and be thoroughly comfortable in speaking with prospective Study Coordinators.
- Must be proficient in collaborative problem-solving skills
- Required Educational minimum: BA/BS
- 1-3 years of experience in Clinical Trial Safety Reporting, and Good Clinical Practices (GCP) is desired.