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Clinical Research Operations Manager
2 months ago
Position Overview: Medix™ is looking for a skilled and proactive Clinical Research Site Manager to oversee the comprehensive operations of our clinical research facility. The Site Manager will be tasked with directing daily research activities, ensuring adherence to regulatory requirements, and shaping the strategic vision for the site's research programs. This position demands exceptional leadership capabilities, a deep understanding of clinical research methodologies, and the ability to cultivate teamwork to meet research goals.
Core Responsibilities:
Leadership and Oversight:
- Direct and supervise the clinical research personnel, including coordinators, investigators, and administrative staff.
- Formulate and execute strategic initiatives to fulfill site objectives.
- Guarantee the smooth and effective functioning of the research facility, encompassing resource management, financial planning, and staffing needs.
Trial Management:
- Supervise the execution of clinical trials, ensuring compliance with study protocols, timelines, and regulatory standards.
- Track study advancements and promptly address any challenges or discrepancies.
- Ensure all trials are conducted in accordance with Good Clinical Practice (GCP), FDA guidelines, and institutional protocols.
Regulatory Adherence:
- Manage the preparation and submission of necessary documentation to Institutional Review Boards (IRBs) and regulatory bodies.
- Ensure all research activities align with ethical principles and regulatory frameworks.
- Maintain and revise site Standard Operating Procedures (SOPs), ensuring all team members are trained and compliant.
Quality Control:
- Establish and oversee quality assurance measures to safeguard data integrity and participant safety.
- Conduct routine audits of study documentation and processes to verify compliance with regulatory standards.
- Address and rectify any issues identified during audits or inspections.
Business Development:
- Foster and sustain relationships with sponsors, Contract Research Organizations (CROs), and other key stakeholders.
- Identify and pursue new clinical trial opportunities and research partnerships.
- Represent the research facility at industry conferences, meetings, and networking functions.
Team Development:
- Guide and nurture the clinical research team, promoting a culture of ongoing education and enhancement.
- Offer training and professional growth opportunities for staff to elevate their expertise and competencies.
