Clinical Site Director

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Job Purpose

Responsible for clinic operations at site. Control study production functions. Responsible for client interaction and client satisfaction with the conduct of studies.

This position impacts revenue and profits for the site.

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

Celerion Values : Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

PI254083942