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Clinical Research Site Manager
2 months ago
Overview: We are seeking an experienced and dynamic Clinical Research Site Director to lead and oversee all aspects of clinical research operations at our site. The Site Director will be responsible for managing the day-to-day activities of the research site, ensuring compliance with regulatory standards, and driving the strategic direction of the site’s research initiatives. This role requires strong leadership skills, extensive knowledge of clinical research, and the ability to foster collaboration across teams to achieve research objectives.
Key Responsibilities:
Leadership and Management:
- Lead and manage the clinical research team, including coordinators, investigators, and support staff.
- Develop and implement strategic plans to achieve site goals and objectives.
- Ensure the efficient and effective operation of the research site, including resource allocation, budgeting, and staffing.
Study Oversight:
- Oversee the conduct of clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements.
- Monitor study progress and address any issues or deviations promptly.
- Ensure that all studies are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies.
Regulatory Compliance:
- Oversee the preparation and submission of documents to Institutional Review Boards (IRBs) and regulatory agencies.
- Ensure that all research activities comply with ethical standards and regulatory guidelines.
- Maintain and update site SOPs, ensuring that all staff are trained and compliant.
Quality Assurance:
- Implement and monitor quality control processes to ensure the integrity of data and the safety of participants.
- Conduct regular audits of study documentation and processes to ensure compliance with regulatory requirements.
- Address and resolve any findings from audits or inspections.
Business Development:
- Build and maintain relationships with sponsors, CROs, and other stakeholders.
- Identify and pursue opportunities for new clinical trials and research collaborations.
- Represent the research site at industry meetings, conferences, and networking events.
Team Development:
- Mentor and develop the clinical research team, fostering a culture of continuous learning and improvement.
- Provide training and professional development opportunities for staff to enhance their skills and knowledge.
