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Job #02897

About our client Our client is a small start-up biotech company located in the Midwest. They have a promising compound for age-related macular degeneration. They offer strong bonuses and stock options to their entrepreneurial employees. Position Location Clinical Research Associate Midwest Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare and execute clinical investigations 2) Oversee all aspects of study monitoring for CROs 3) Participate in investigator site selection 4) Coordinate vendor/CRO services 5) Initiate, review and negotiate site budgets/contracts 6) Participate in and handle the organization of sponsor and investigator meetings 7) Review, revise and develop SOPs 8) Schedule and monitor clinical investigational sites 9) Design/prepare CRFs 10) Generate study specific monitoring plans and informed consent templates 11) Prepare clinical study supplies to be shipped to the investigational sites 12) Provide guidance on the use of clinical supplies 13) Register patients for clinical investigations 14) Interact (daily) with appropriate individuals, departments or contractors to support and maintain clinical investigations 15) Assist in updating of the Investigator's brochure and final study reports for assigned protocols 16) Collect, process, review and make corrections to CRFs 17) Document and maintain all site contacts on appropriate forms 18) Review tables, listings and study reports for assigned protocols 19) Act as the Lead Monitor of assigned protocols and/or projects 20) Participate (actively) in Clinical Team meetings and lead discussions on assigned protocols 21) Maintain awareness of and follow company SOPs, GCPs and ICH guidelines 22) Review literature (as required) 23) Prepare timely reports on the status of clinical investigations 24) Assist in the preparation and completion of IND, BLA, and NDA documents, as well as product annual reports, and final safety reports 25) Train and supervise CRO personnel to ensure consistency and compliance in monitoring of clinical investigations 26) Participate in internal/external audits Requirements 1) RN or BSN (Nursing), BS or BA in Life Sciences, Pharmacy or Medicine 2) 2+ years of progressively increasing clinical research experience (in the pharmaceutical industry) 3) Experience in a small biotech environment preferred 4) Experience in organizing and the administration of early stage (Phase I or Small Stage II) and late-stage clinical trials a plus 5) Experience in ophthalmology 6) Experience in drug development (FDA regulations, GCPs or Associates of Clinical Pharmacology CRA certification) 7) Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems under supervision 8) Ability to prepare summary reports as well as deliver clear and concise presentations