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Job #02726

About our client Our client is a rapidly growing biopharmaceutical company headquartered in Maryland that is focused on the development and commercialization of various autoimmune and oncology therapeutics. The company has an experienced management team, a varied selection of protocols and an empowering culture that is focused on the long-term professional development of its employees. Position Location Clinical Research Associate (In-House) Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Serve as the primary contact for a study and assume leadership role for specific protocol(s) 2) Work with the Study Team to select clinical sites and develop timelines and budgets 3) Ensure proper documentation as well as lead handling of study-related issues 4) Manage study timelines 5) Lead the Clinical Team meetings and keep the Project Team members informed of study progress, issues and potential timeline delays 6) Read and interpret (critically) relevant literature 7) Work with the Clinical Project Manager on vendor-selection process and ongoing vendor management (including CRO, Central Laboratory, IVRS, etc.) 8) Supervise other clinical operations staff Requirements 1) College degree (Health care or Life Sciences preferred) 2) Minimum 5 years of clinical trial experience, with 2 years in the Lead CRA capacity 3) Experience in and knowledge of therapeutics (i.e. oncology, cardiology or infectious diseases except skin care and medical devices) 4) Experience in domestic and international clinical trials 5) Familiarity with drug names, diagnosis and medical terminology 6) Good understanding of ICH, CCP and relevant regulatory requirements 7) Ability to act independently 8) Demonstrated communication and problem-solving skills 9) Willingness to travel – up to 30%