Site Director

Job Description

Job DescriptionSummary: The Site Director manages the daily operations of a clinical research site, ensuring compliance with regulatory standards and the efficient execution of clinical trials. They lead the site team, oversee participant recruitment and retention, and ensure study timelines and quality objectives are met. The Site Director also handles budgeting, resource management, and fosters a positive work environment. Additionally, this role includes overseeing dialysis trials specifically conducted at the Michigan site.

Duties and Responsibilities: TheSite Director:

• Manages the planning, initiation, and execution of dialysis-related clinical trials sites, ensuring adherence to protocol and regulatory standards.
• Develops and executes the site’s strategic plan in alignment with the Company’s goals and objectives.
• Evaluates site performance and recommends improvements.
• Collaborates with clinical, regulatory, and safety teams to manage risk, safety, and quality in clinical trials.
• Promptly reports to Company Management concerns or limitations in the performance of a clinical research study.
• Leads, mentors, and motivates staff to deliver high-quality services.
• Implements ongoing training programs for staff to stay up to date with the latest regulatory standards.
• Collaborates with executive leadership to develop and meet organizational goals while providing expertise on projects, operations, and systems.
• Identifies and recommends new technologies and systems to improve organizational processes and decision-making.
• Ensures that projects are completed within budget and in an economical manner.
• Prepares or acquires cost analysis for development projects and schedules project completion dates.
• Establishes and administers the department’s budget.
• Ensures consistent employee performance evaluations across the site.
• Partners with Human Resources to review candidate credentials, conduct interviews, and provide input on new hires.
• Performs staff terminations as needed.
• Oversees employee scheduling, ensuring coverage of site services and coordination of time off.
• Supervises Clinical Research Coordinators, Research Assistants, and support staff, conducting performance reviews and taking disciplinary actions as necessary.
• Fosters a culture of continuous learning and professional development.
• Maintains up-to-date knowledge of relevant regulatory guidelines and ensures compliance with FDA, ICH, and local regulatory agencies.
• Implements and maintains quality assurance processes to uphold data integrity and patient safety.
• Prepares for and participates in audits conducted by sponsors, federal agencies, or review groups.
• Oversees the planning, initiation, and execution of clinical trials at the site.
• Maintains required study records, including case report forms, drug dispensation records, and regulatory forms.
• Manages patient recruitment and retention efforts, optimizing subject enrollment and ensuring informed consent is properly obtained.
• Ensures patients receive the highest standard of care during clinical trials and addresses any concerns promptly.
• Instructs staff on scientific and procedural aspects of studies, including standards of care and documentation procedures.
• Acts as the primary liaison between the site, sponsors, CROs, and regulatory agencies, maintaining open communication channels with all stakeholders.
• Prepares and reviews study-related documentation such as protocols, progress reports, and adverse event reports.
• Reviews proposed study protocols and evaluates sample collection processes, data management plans, and potential subject risks.
• Orders necessary drugs or devices for study completion.
• Occasional travel to company sites, investigator meetings, and/or company meetings.
• Performs other duties as assigned.

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:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 20 pounds at a time.
• Exposure to human bodily fluids
• Travel to sponsor required meetings as needed.