RESPONSIBILITIES

• 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 PIs 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 SOPs based on different sponsor requirements
• Lead the meeting with the sponsor, discussing patient recruitment strategies, and reviewing the sites 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 mentalitytakes responsibility for outcomes and drives results.
• Ability to handle high-stress situations.