The Director of Clinical Research is the leader of our clinical research program reporting directly to the CEO. This position will have full responsibility for the small department, including development and implementation of the clinical trial strategy, directing all clinical study activities, and ensuring good clinical practices are in place. Ensures efficient execution of trials within established budgets and timelines, and compliance with appropriate regulations, including FDA, privacy, IRB, and ICH requirements. Responsible for on-label post-market descriptive and investigational studies, as well as pilot and pivotal studies supporting regulatory registration. Coordinates the efforts of internal and external resources to ensure sound study design, careful site selection, rapid subject recruitment, trial plan optimization and execution of trials with a focus on quality, innovation, and efficiency. Studies will be conducted in-house by the clinical research staff and with support from external vendors including contract research organizations.
ESSENTIAL DUTIES & RESPONSIBILITIES
EDUCATION, EXPERIENCE & TRAINING REQUIRED
PHYSICAL POSITION REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Regenesis offers competitive pay, bonus plan, stock plan, health insurance benefits, matching 401k, and a generous paid time off plan.
Regenesis Biomedical is an Equal Opportunity Employer