Director Clinical Sites

• Lead clinical trial sites and multi-disciplinary site teams in USA and maintain oversight of site staff including CRCs and ensure the smooth operation of ongoing clinical trials

• Maintain close coordination with network sites Principal Investigators

• Foster ongoing communication and collaboration between clinical research teams, site coordinators, and regulatory teams to ensure timely progress

• Ensure that information regarding recruitment, protocol adherence, and study milestones is shared across all stakeholders

• Schedule regular check-in meetings with site staff and internal teams to provide updates and discuss any challenges

• Ensure that any bottlenecks in recruitment, protocol adherence, or data collection are addressed promptly

• Coordinate closely with Marketing to review the business development plan for the site, usually identified based on expertise that the PI’s suggest

• Set weekly business development goals, such as identifying new opportunities for clinical trials, reaching out to potential sponsors, or preparing for upcoming site qualification visits

• Coordinate with sponsors or CROs (Contract Research Organizations) to schedule PSSV

• Ensure the site team is prepared with necessary documentation, facilities, and equipment for the visit

• Continue to evolve and create new SOP’s based on different sponsor requirements

• Lead the meeting with the sponsor, discussing patient recruitment strategies, and reviewing the site’s facilities and capabilities

• Review the performance metrics of ongoing studies, including recruitment rates, retention rates, and subject safety

• Address any site performance concerns with study coordinators and resolve any issues to ensure the site is meeting sponsor expectations

• Ensure that all stakeholders, including sponsors and monitors, have access to the most up-to-date information available in SiteVault, ensuring transparency and quick access during audits or monitoring visits

• Address any findings or discrepancies uncovered during the audit by providing a detailed corrective and preventive action (CAPA) plan

• Document the resolution of these issues and ensure that any non-compliance or findings are appropriately followed up on and corrected before further progress.

● Onboard new clinical research coordinators and site staff by providing in-depth training on trial protocols, regulatory requirements, and site-specific procedures.

● Provide them with comprehensive training on data entry, patient recruitment, and handling clinical trial documentation

EXPERIENCE AND QUALIFICATIONS

• Proven experience in a leadership role, with a demonstrated ability to effectively supervise and develop clinical staff

• Strong ability to work independently, take initiative, and drive projects to completion with minimal oversight.

• Exceptional organizational, problem-solving, and decision-making skills.

• Excellent written and verbal communication skills.

• Strong work ethic, integrity, and professionalism.

• Creative, innovative, and solution-oriented mindset.

• Ownership mentality—takes responsibility for outcomes and drives results.

• Ability to handle high-stress situations.