Job Description

Operational Oversight

• Site Optimization: Manage day-to-day clinic activities to ensure peak performance and goal alignment.
• Study Planning: Lead protocol reviews and feasibility assessments to ensure successful study selection and enrollment.
• Resource Management: Oversee site staffing, space allocation, and cost-control measures.

Team Leadership

• Staff Management: Hire, train, and mentor clinical staff while holding them accountable to performance standards.
• Compliance & Quality: Ensure all activities adhere to SOPs, FDA regulations, and Good Clinical Practice (GCP).
• Workload Coordination: Manage staff schedules and delegate tasks to maintain efficient site workflow.

Clinical & Regulatory Management

• Trial Execution: Oversee the lifecycle of the study, from Site Initiation Visits (SIVs) to final study close-out.
• Data Integrity: Ensure source documents and Case Report Forms (CRFs) are completed with high accuracy.
• Recruitment: Drive site-wide efforts to meet or exceed participant enrollment and retention targets.

Stakeholder Relations

• Investigator Liaison: Maintain strong, collaborative relationships with Principal Investigators to ensure proper oversight.
• Sponsor Communication: Act as the primary point of professional contact for sponsors, CROs, and monitors.

Core Requirements

• Industry Experience: Minimum of 3+ years of direct experience within the Clinical Research field.
• Leadership Background: Prior experience in a supervisory or management role, or a clear track record of leading clinical teams and projects.
• Technical Proficiency: Comprehensive understanding of GCP (Good Clinical Practice), FDA regulations, and ICH guidelines.
• Operational Knowledge: Familiarity with the full study lifecycle, including regulatory submissions, clinical procedures, and sponsor/monitor interactions.
• Communication Skills: Exceptional verbal and written communication skills, with the ability to translate complex scientific/medical language into actionable information.
• Mobility: A valid driver’s license and the ability to commute between various site locations as needed (up to 20% travel).
• Physical Ability: Capacity to lift up to 15 lbs and maintain availability during standard business hours for remote and onsite tasks.

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