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 PurposeResponsible 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 responsibilityProfitability (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 recognitionClient 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 improvementsGeneral 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 standardizationKnowledge / 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 skillsCelerion Values : Integrity Trust Teamwork RespectAre 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.