Site Director (CRC)
About The Position
The Site Director is responsible for the overall leadership, strategic direction, and operational management of the clinical research site. This role ensures the successful execution of clinical trials in compliance with regulatory requirements, sponsor expectations, and organizational goals, while fostering a culture of excellence, integrity, and patient-centered care. The Site Director will report directly to the Chief Operating Officer. The Site Director oversees all aspects of clinical trial operations at Johnson County Clinical Trials and starting a new De Novo site in North Kansas City. Oversights include staff management, financial performance, regulatory compliance, and sponsor relations. This position plays a critical role in maintaining high standards of research quality, implementation of protocols, study participant safety, and operational efficiency. The Site Director collaborates with internal teams and external stakeholders to drive growth, innovation, and continuous improvement in clinical research delivery.
Requirements
- Bachelor’s degree in Life Sciences, Nursing, Healthcare Administration, or related field required.
- Minimum of 6 years of experience in clinical research, with at least 3 years in a leadership or site management role.
- Experience coordinating clinical trials in multiple therapeutic areas.
- Proven track record of managing multi-therapeutic clinical trials and leading cross-functional teams.
- Experience with FDA, ICH-GCP, and other regulatory guidelines.
- Strong background in budget management, contract negotiation, and financial oversight.
- Exceptional leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC), and Microsoft Office Suite.
- Commitment to ethical research practices and participant safety.
- Demonstrated proficiency with word processing, spreadsheet, database, e-source, e-CRF, e-Regulatory software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint).
- Ability to sit or stand for extended periods while working at a computer or attending meetings.
- Occasional lifting of office supplies, documents, or equipment up to 25 pounds.
- Ability to move throughout the clinical site, including patient areas, labs, and administrative offices.
- Visual acuity to read and interpret documents, data, and computer screens.
- Manual dexterity for operating office equipment and performing basic clinical tasks.
- May require occasional travel to sponsor meetings, conferences, or other clinical sites.
Nice To Haves
- Master’s degree (e.g., MBA, MPH, MSN, or equivalent) preferred.
- CCRC or CCRP certification preferred.
Responsibilities
- Leadership & Strategic Management: Develop and implement site-level strategies aligned with organizational goals. Lead and mentor clinical and administrative staff to ensure high performance and professional development. Foster a collaborative and inclusive work environment.
- Clinical Operations: Oversee the execution of clinical trials from initiation to close-out. Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements. Ensure adherence to Good Laboratory Practice (GLP). Monitor site performance metrics including enrollment, retention, and protocol compliance.
- Quality & Compliance: Maintain site readiness for audits and inspections. Implement and monitor quality assurance processes. Address protocol deviations, adverse events, and corrective actions promptly.
- Financial Oversight: Manage site budgets, including forecasting, cost control, and financial reporting. Supports contracts and budgets with sponsors and CROs. Ensure billing compliance and timely invoice.
- Stakeholder Engagement: Serve as the primary point of contact for sponsors, CROs, and regulatory bodies. Build and maintain strong relationships with investigators, referring physicians, and community partners. Represent the site at industry meetings and conferences.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
