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Medpace Inc Regulatory Submissions (Study Start Up) Coordinator - Denver in Denver, Colorado

Regulatory Submissions (Study Start Up) Coordinator - DenverJob LocationsUnited States-CO-DenverCategoryClinical OperationsOverviewMedpace is a full-service clinical contract research organization (CRO).We provide Phase I-IV clinical development services to the biotechnology,pharmaceutical and medical device industries. Our mission is to accelerate theglobal development of safe and effective medical therapeutics through itsscientific and disciplined approach. We leverage local regulatory andtherapeutic expertise across all major areas including oncology,cardiology, metabolic disease, endocrinology, central nervous system,anti-viral and anti-infective. Headquartered in Cincinnati, Ohio,employing approximately 3,500 people across almost 40 countries.Job SummaryOur clinical operations activities are growing rapidly, and we are currentlyseeking a full-time, office-based Regulatory Submissions Coordinator to joinour Clinical Operations team. This position works both independently andcollaboratively with a team to meet common goals and plays a key role in theclinical trial management and study start-up process at Medpace. We haveopenings ranging from entry to senior coordinator to best match yourexperience level. If you want an exciting career where you use your previousexpertise and can develop and grow your career even further, then this isthe opportunity for you.ResponsibilitiesCommunicate with research sites (doctor's offices, universities,hospitals, etc.) to collect all essential documents required before thesite begins to screen patients to participate in the clinical trial;Maintain and perform ongoing quality review of trial documents within theTrial Master File (TMF);Collect, review, organize, and assemble regulatory start-up submissions(includes submissions to Institutional Review Boards, or IRB);Maintain timelines for study start-up through both internal and externalcollaboration;Provide advice and guidance to internal and external team members to ensurecompliance with applicable regulations and requirements; andReview pertinent regulations and guidance to develop proactive solutions toregulatory issues and challenges.SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experiencedassociates, as well as those that are new to the industry. The SAM TrainingProgram embraces evidence based learning & development models to advanceprofessional learning and employee performance. In the program, you will...Complete independent learning modules, interactive exercises, and teamworkshops through the core curriculum;Gain exposure to real-world tasks through a robust mentoring program; andJoin other professionals revolutionizing efficient and seamless study start-upto advance clinical trials.QualificationsA minimum of a Bachelor's degree is required (preferably in a LifeSciences field);Experience as a Clinical Research Coordinator (minimum 1 year);Excellent organizational and prioritization skills;Some experience with Institutional Review Board (IRB) submissions andInformed Consent Form development is preferred;Knowledge of Microsoft Office; andGreat attention to detail and excellent oral and written communication skills.CompensationA target salary range of $35,000 - $65,000. Your compensation will bebased on your skills and experience. Medpace offers the following benefits foreligible positions: medical, dental, vision, 401(k), vacationpolicy, sick days, paid holidays, work from home flexibility,short-term disability, long-term disability, health savings and flexiblesavings accounts, life and AD&D insurance, and pet insurance. For moredetails, please discuss with your recruiter.Why Medpace?When you join Medpace, you become part of a team dedicated to supporting thedevelopment of ground-breaking drugs and devices. Our employees provide hopefor those living with debilitating diseases. We invite you to be a part ofsomething that is impacting millions of people around the globe

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