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Clinical Trials Site Supervisor
2 months ago
Position Overview: Medix™ is in search of a proficient and proactive Clinical Research Site Manager to spearhead and manage all facets of clinical research activities at our facility. The Site Manager will play a pivotal role in overseeing the daily operations of the research site, ensuring adherence to regulatory standards, and steering the strategic vision of the site's research projects. This position demands exceptional leadership capabilities, comprehensive knowledge of clinical research, and the ability to cultivate teamwork across various departments to fulfill research goals.
Primary Responsibilities:
Leadership and Oversight:
- Direct and supervise the clinical research team, including research coordinators, principal investigators, and support personnel.
- Formulate and execute strategic initiatives to meet site objectives and targets.
- Guarantee the smooth and effective functioning of the research site, encompassing resource management, financial planning, and staffing.
Trial Management:
- Supervise the execution of clinical trials, ensuring compliance with study protocols, timelines, and regulatory standards.
- Track study advancement and promptly address any challenges or discrepancies.
- Ensure that all trials are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, and institutional policies.
Regulatory Adherence:
- Oversee the preparation and submission of necessary documentation to Institutional Review Boards (IRBs) and regulatory bodies.
- Ensure that all research operations align with ethical standards and regulatory guidelines.
- Maintain and revise site Standard Operating Procedures (SOPs), ensuring that all personnel are trained and compliant.
Quality Control:
- Establish and monitor quality assurance processes to uphold data integrity and participant safety.
- Conduct routine audits of study documentation and procedures to verify compliance with regulatory requirements.
- Address and rectify any findings from audits or inspections.
Business Growth:
- Foster and maintain relationships with sponsors, Contract Research Organizations (CROs), and other key stakeholders.
- Identify and explore opportunities for new clinical trials and research partnerships.
- Represent the research site at industry conferences, meetings, and networking events.
Team Development:
- Guide and develop the clinical research team, promoting a culture of ongoing learning and enhancement.
- Provide training and professional development opportunities for staff to elevate their skills and expertise.
