Clinical Site Director

Essential Functions

• Responsible for staff management in accordance with the organization’s policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees. (10%)

Quality (20%)

• Responsible for on-time performance and defect-free execution of studies at clinical site
• Establish processes to ensure compliance with client protocols, Standard operating Procedures (SOPs)  and federal regulations
• Responsible for Quality Assurance (QA) site audits within required timeframes
• Implement necessary changes resulting from QA audits and client audits
• Assist in developing SOPs for all areas of responsibility

Profitability (30%)

• Maintain profitability of the site through budgeting and expense control
• Analyze financial statements on a monthly basis to ensure margin targets are met
• Review General Ledger (G/L) detail on a monthly basis to Identify any expense discrepancies
• Resolve any G/L expense discrepancies with accounting department
• Identify potential cost reductions to increase site profitability
• Review revenue projections on a weekly basis to ensure all confirmed studies are taken into account
• Attend scheduling meetings to ensure site revenue targets are met
• Assist in determination of feasibility at the site based on staff, equipment, expertise, and potential patient/participant recruitment capabilities
• Work with accounting department to develop relevant analysis tools (revenue/Full-time Equivalents (FTE), margin/FTE)
• Coordinate with purchasing department to ensure expense control
• Approve all site purchases
• Approve all client discounts and absorbed change orders
• Work with accounting department to update them on patient enrollment and completion of all patient studies to ensure correct revenue recognition

Client Interaction (20%)

• Represent clinical site during site evaluation visits and site audits
• Respond to client inquiries and concerns
• Develop a client-focused clinical site
• Build community relationships
• Help identify physician resources
• Review participant surveys and implement necessary changes or improvements
• Review client surveys and implement necessary changes or improvements

General and Site Management (20%)

• Develop and compile metrics for all areas of responsibility
• Evaluate procedures for efficiency and effectiveness in areas of responsibility
• Provide monthly site reports (Quality/Zero-Defect, On-Time Performance, Occupancy, Financial Analysis, Client Visits, Readiness to Serve)
• Coordinate facility management and related activities
• Provide management and leadership to clinical operations, participant and patient recruitment, clinical data management, and relevant support functions
• Attend relevant meetings and conference calls to ensure global awareness and standardization

Knowledge/Skills/Education/Licenses

• Bachelor’s degree in Business, Science or health-related field
• 5 years experience in clinical research, preferably at a CRO, with emphasis on Phase 1 experience
• 5 years management experience
• Ability to manage multiple priorities
• Excellent oral and written communication skills