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Senior Research Director
2 months ago
Care Access is seeking a highly skilled and experienced Senior Research Director to oversee the conduct of clinical trials and ensure compliance with federal and industry regulations. The ideal candidate will have a strong background in research and a proven track record of managing complex studies.
Key Responsibilities- Develop and implement research strategies to achieve study goals and objectives
- Oversee the conduct of clinical trials, including protocol development, site management, and data collection
- Ensure compliance with federal and industry regulations, including ICH-GCP and local regulations
- Collaborate with internal research teams to review inclusion/exclusion criteria, endpoint criteria, and investigational article use
- Assess subject response to therapy, evaluate and address adverse experiences
- Meet regularly with research teams to discuss subject participation and protocol progress
- Train sub-investigators and study staff on protocol and protocol-specific procedures
- Provide medical support to sub-investigators and study staff for protocol-related issues
- Maintain essential documents and records necessary for the conduct of the study
- Implement Care Access Standard Operating Procedures
- Review sponsor-provided safety reports
- Review and maintain accurate case report forms
- Sign off electronic case books as required by the study sponsor
- Provide clinical oversight and quality of the studies
- Ensure the medical well-being and safety of study participants
- Participate in driving delivery of study targets, such as participant recruitment, enrollment, and retention
- MD/DO license in good standing
- Board certification in Internal Medicine, Cardiology, Gastroenterology, Dermatology, Endocrinology, Emergency Medicine, Family Practice, or related field
- Prior research experience preferred
Care Access is an equal opportunity employer and offers a competitive salary and benefits package. We value diversity and believe that unique contributions drive our success. We are committed to advancing medical breakthroughs and improving patient care.