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 FunctionsResponsible 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 siteEstablish processes to ensure compliance with client protocols, Standard operating Procedures (SOPs)  and federal regulationsResponsible for Quality Assurance (QA) site audits within required timeframesImplement necessary changes resulting from QA audits and client auditsAssist in developing SOPs for all areas of responsibilityProfitability (30%)Maintain profitability of the site through budgeting and expense controlAnalyze financial statements on a monthly basis to ensure margin targets are metReview General Ledger (G/L) detail on a monthly basis to Identify any expense discrepanciesResolve any G/L expense discrepancies with accounting departmentIdentify potential cost reductions to increase site profitabilityReview revenue projections on a weekly basis to ensure all confirmed studies are taken into accountAttend scheduling meetings to ensure site revenue targets are metAssist in determination of feasibility at the site based on staff, equipment, expertise, and potential patient/participant recruitment capabilitiesWork with accounting department to develop relevant analysis tools (revenue/Full-time Equivalents (FTE), margin/FTE)Coordinate with purchasing department to ensure expense controlApprove all site purchasesApprove all client discounts and absorbed change ordersWork 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 auditsRespond to client inquiries and concernsDevelop a client-focused clinical siteBuild community relationshipsHelp identify physician resourcesReview participant surveys and implement necessary changes or improvementsReview client surveys and implement necessary changes or improvementsGeneral and Site Management (20%)Develop and compile metrics for all areas of responsibilityEvaluate procedures for efficiency and effectiveness in areas of responsibilityProvide monthly site reports (Quality/Zero-Defect, On-Time Performance, Occupancy, Financial Analysis, Client Visits, Readiness to Serve)Coordinate facility management and related activitiesProvide management and leadership to clinical operations, participant and patient recruitment, clinical data management, and relevant support functionsAttend relevant meetings and conference calls to ensure global awareness and standardizationKnowledge/Skills/Education/LicensesBachelor's degree in Business, Science or health-related field5 years experience in clinical research, preferably at a CRO, with emphasis on Phase 1 experience5 years management experienceAbility to manage multiple prioritiesExcellent oral and written communication skillsCelerion Values:       Integrity   Trust   Teamwork   Respect
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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.