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.  
Responsible for operation, management and conduct of clinical studies. Ensure compliance, quality, and profitabilityEssential 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.Overall management of clinical studiesOn-time performance with defect-free executionWork with Clinical Support Coordinator, study design and recruiting to schedule studies Set up study initiation meetings to plan execution of studyConduct study review meetings for pre-study, in-process and post-study reviewProblem solve as needed during study conductMeet with clients as needed throughout studyOrganize study logistics and personnelBe present at critical events and dosings of studyEnsure profitabilityMaintain profitability of team through budgeting and expense control on a total and individual study basisMonitor overtimeCoordinate with purchasing to ensure expense controlStaff management/study preparationInterpret and implement study specification sheetManage/supervise associates during study conductAssign duties to clinic staffAssess and take action as special situations occur in study conductEnsure timely and accurate data is collectedEnsure compliance and qualityEnsure compliance with client protocol, Standard Operating Procedures and federal regulationsRespond to Quality Assurance audits in timely mannerImplement monthly meetings to review management reportsBuild relationships with communityIdentify physician resourcesEnhance marketing and recruitingProvide client services to consumer product and clientsAssume responsibility for facility managementFeesNew business opportunitiesDevelop opportunities for computerization of alternative methods of data entry; bar-coding, utilizing specs/Time & Event ScheduleIdentify additional training requirements (outpatient) for Clinical Research Tech training manualsKnowledge/Skills/Education/LicensesBachelor’s degree in Business, Science or health-related field or BSNProven organizational skillsAbility to manage multiple prioritiesExcellent oral and written communication skillsKnowledge of medical terminology preferredAbility to work without close supervisionAbility to work hours required for study conductLevel based on years of experience in medical, pharmaceutical or related field of operationsAbility to work flexible scheduleCelerion 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.