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Job #02316

About our client Our client is focused on diabetes and cancer. The biopharmaceutical company is into the discovery, development and commercialization of therapeutics products for these diseases. Phase 3 clinical trials are going on for its lead investigational product for treatment of diabetes in US, Latin America and Europe. Position Location Lead Clinical Research Associate Los Angeles/Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan, conduct and track clinical research studies in compliance with ICH GCP/FDA guidelines and Standard Operating Procedures, etc. 2) Ensure clinical trial and monitoring management quality and consistency of performance 3) Work in conjunction with the Clinical Trial Manager (CTM) and other inter and intra-departmental personnel 4) Ensure adequate resource volume and quality is maintained on the studies 5) Work directly with office and regional CRAs 6) Review protocol CRF/CRF instructions 7) Provide input to the CTM or Medical Writer regarding logistics involved in the conduct of the protocol from Phase I-IV, including Health Economics studies 8) Develop and/or review the Informed Consent Form for assigned trials 9) Prepare investigator meetings and CRA training materials and participate in training presentations 10) Prepare materials for and actively participate in identification of investigator sites and team CRAs (Clinical Research Associates) 11) Develop tools and distribute them for conducting trials, including monitoring plans, source document template, pharmacy manuals, newsletters 12) Participate in evaluating recruitment vendors 13) Create subject recruitment plan(s) to meet planned trial enrollment rates in conjunction with CRAs/CROs 14) Create template presentations for trial start-up visits 15) Oversee CRA activities in the field and co-monitor with them to evaluate protocol-specific and general monitoring practices 16) Serve as primary contact for CRAs regarding questions, issues and problems 17) Organize weekly CRA meetings to update information regarding monitoring and site management activities 18) Track CRA field activities and review site visit reports 19) Evaluate and report trends to CTM/CRO management 20) Ensure routine and final CRF retrieval per plan 21) Authorize CRA travel and seek appropriate approvals 22) Participate and/or organize, with Data Management, in-house review of clinical data, including DCFs prior to site/CRA distribution 23) Oversee tracking of enrollment and investigator payments issues for assigned clinical trials 24) Participate in management of outside vendors, such as contract research organizations, central labs and independent contractors 25) Ensure regular updates of clinical trial tracking systems, including collection and filing of protocol exceptions 26) Participate with CTM in managing outside vendors such as contract research organizations and independent contractors 27) Complete and send weekly reports to the CTM 28) Serve on various in-house infrastructure development or improvement teams or committees (e.g., SOP, process improvement) at the discretion of management 29) Mentor clinical research associates 30) Ensure appropriate identification, documentation and reporting of safety issues 31) Direct supervisory responsibilities for the CTA (Clinical Trial Assistant) 32) Assist in clinical trial development and help recognize medical issues of safety related to the diseases and drugs under research Requirements 1) Degree (4 years) in Life Sciences or a science-related field 2) 5 years of experience in the pharmaceutical industry or drug approval process 3) 3 years of experience as a Clinical Research Associate or equivalent experience 4) Strong knowledge of and competence in application of CFRs, GCPs and ICH guidelines 5) Familiarity with clinical research methodology 6) Adequate medical knowledge 7) Command over medical terminology and the application of scientific/medical and clinical concepts used to conduct clinical trials 8) Strong knowledge and understanding of scientific and medical processes in the assigned therapeutic area 9) Knowledge and demonstrated ability to effectively manage a clinical trial with minimum supervision 10) Direct CRA management experience and considerable understanding of the challenges faced by CRAs in the field 11) Excellent communication skills 12) Willingness to travel – up to 20-25% in a year and 50% in a month