Our high growth clinical research start-up is seeking a Fractional Medical Director for our dynamic team. We are a two year old company with multiple sites across the southeast. This role will help us assess trial protocols for selection and execution as well as play a role in training our emerging research investigators using our curriculum. Additionally our medical Director provide support to the investigators with recruitment and clinical operational challenges. This is a fully remote role. Must be reasonably available during the regular work day at for virtual meetings and email exchange. Private practice research experience is a plus for this role. 15 hours per month.
Location: Remote - US Based
Position Summary: The Medical Director will play a key role in providing medical oversight for Investigator activities, protocol review and appropriate execution within the organization.
Key Responsibilities:
Clinical Oversight:
- Provide medical oversight and guidance to ensure the ethical and scientific integrity of clinical research projects.
- Review, provide insights and approve clinical trial protocols for practical application at the site level.
- Liaison with Principal Investigators across all sites to introduce clinical research and provide a brief review of responsibilities (when needed).
Regulatory Compliance:
- Stay abreast of regulatory guidelines and ensure that clinical research activities adhere to regulatory requirements.
Study Design and Planning:
- Contribute to the assessment of clinical study protocols, and other clinical study-related documents.
- Participate in the planning and execution of clinical trials from a medical perspective
- Provide a consultative approach to improving recruitment and study responsibilities as needed to Investigators and study team.
Clinical Team Oversight:
- Provide medical leadership to the Investigator clinical team, fostering a collaborative and high-performance culture.
- Mentor and guide medical and clinical staff, ensuring professional development and adherence to quality standards.
Collaboration and Communication:
- Communicate effectively with key stakeholders, including investigators, study coordinators, and leadership.
Qualifications:
Medical Doctor (MD) or equivalent degree
Board Certification
Minimum 15 years of experience in clinical research and drug development
Strong knowledge of regulatory requirements and guidelines
Excellent leadership and communication skills
This is a remote position.