Regional Site Director - Elixia : Job Details

Midwest region (based near St. Peters, Missouri)

Summary: The Regional Site Director serves as the Site Director for the St. Peters, Missouri site while supporting the Vice President of Site Operations in overseeing other clinical research sites within the Midwest region. This role involves ensuring compliance with regulatory standards, managing the efficient execution of clinical trials, and leading site teams to meet performance goals. The Regional Site Director manages operations, resource allocation, and staff development, with a particular focus on the St. Peters site while supporting regional site performance.

Duties and Responsibilities: The Regional Site Director:

• Serves as the Site Director for the St. Peters, Missouri site, overseeing day-to-day operations, site performance, and regulatory compliance.
• Assists the Vice President of Site Operations in the development and execution of regional strategies in line with the Company's objectives.
• Evaluates and improves performance across all sites, including leadership of the St. Peters site and conducting performance evaluations for Clinical Research Coordinators, Research Assistants, and other staff across the region.
• Acts as a liaison between the regional sites, sponsors, CROs, and regulatory bodies to ensure effective communication, compliance, and the management of risk, safety, and quality across sites.
• Reports any site-specific concerns or performance limitations to the Vice President of Site Operations.
• Provides leadership and guidance to site teams, helping to mentor and motivate staff across the region.
• Coordinates staff training programs and promotes a culture of continuous learning and professional growth, ensuring compliance with regulatory standards across all sites.
• Works with the Vice President to implement operational goals and provide expertise on site-level challenges and opportunities for improvement.
• Assists in identifying and recommending new technologies and systems to enhance site operations.
• Helps ensure clinical trials are financially efficient, assisting with the preparation, monitoring, and resource allocation for site budgets across all sites.
• Collaborates with Human Resources to review candidate credentials, assist with interviews, and provide input on new hires at regional sites.
• Provides support for staff scheduling across sites, ensuring adequate coverage and time-off coordination.
• Ensures that all sites maintain up-to-date knowledge of relevant regulatory guidelines and remain compliant with FDA, ICH, and local regulatory agencies.
• Helps maintain quality assurance processes to ensure patient safety and data integrity, while preparing for and participating in audits at all regional sites.
• Supports the planning and execution of clinical trials at all regional sites, including overseeing the initiation of the St. Peters, Missouri site.
• Ensures proper maintenance of study records, including case report forms, drug dispensation records, and regulatory documentation.
• Assists with patient recruitment and retention efforts, ensuring enrollment targets are met and informed consent is properly obtained.
• Ensures that patients receive high-quality care and promptly address concerns at regional sites.
• Instructs staff on study-related procedures, documentation, and standards of care.
• Reviews study protocols and related documentation, providing feedback on data management plans, sample collection processes, and potential risks.
• Coordinates the ordering of drugs or devices necessary for study completion across the region.
• Travels to different sites, meetings, and investigator conferences as required.
• Performs other duties as needed.

Requirements:

• Bachelor's degree (preferred)
• Or a degree in nursing or health related field
• Minimum 5 years of Management experience
• Minimum 5 years of Site Director or similar role experience
• Strong supervisory skills to lead research staff effectively
• Ability to collect and manage research data accurately
• Familiarity with documentation review processes in clinical research
• Knowledge of medical terminology relevant to clinical trials management

Competency Requirements:

• Leadership & Team Management
• Project Management
• Excellent Communication skills.
• Problem Solving skills.
• Planning /Organizational Skills
• Customer Service Skills
• Computer Competency in Electronic Data Capture

Physical Requirements and/or environmental factors:

• Approximately 35% travel required.
• Night/weekend work schedules at times.
• Work is normally performed in a typical interior clinical/office environment.
• Prolonged periods of sitting at a desk and working on a computer.
• Lifting of 20 pounds and occasionally more than 20 pounds.