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Regulatory Research Intern

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Overview :Medpace 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 the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic 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 Summary:Our clinical operations activities are growing rapidly, and were currently seeking several full or part-time, office-based interns to supportour Regulatory Submissions team within our Site Activation and Maintenance (SAM) Department. This group plays a key role in the study start-up/site activation process at Medpace by communicating with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in a clinical trial. The Regulatory Submissions Intern will provide support to the Regulatory Submissions Coordinators and Managers as they maintain start-up timelines, review and collect regulatory documents, and proactively identify solutions to regulatory issues.Responsibilities :Provide support to the study start-up team through completion of compliance tasksMaintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);Gain hands-on training and exposure to the clinical trial start-up phase through our Site Activation & Maintenance (SAM) Training Program as outlined below.SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence based learning & development models to advance professional learning and employee performance. In the program, you willComplete independent learning modules, interactive exercises, and team workshops through the core curriculum;Gain exposure to real-world tasks through a robust mentoring program; andJoin otherprofessionals revolutionizing efficient and seamless study start-up to advance clinical trials.Qualifications :High School Diploma, pursuing Bachelors degree in business or life science preferredExcellent organizational and prioritization skillsKnowledge of Microsoft OfficeAvailability to work a minimum of 20 hours per week in our Cincinnati, OH office. Full-time preferred.Travel: NoneWhy Medpace?:When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.Awards:Medpace historically named a Top Cincinnati Workplace by the Cincinnati EnquirerRecognized by Forbes as one of America's Best Mid-size Companies in 2021Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next:A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.EO/AA Employer M/F/Disability/Vets*WARNING:Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
Associated topics: antibody, biopharmaceutical, histology, industrial hygienist, metabolism, microbiological, patient, pharmacology, pharmacometrics, toxicologist
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