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Job #02616

About our client Our client is an emerging west coast-based biopharmaceutical company dedicated to the discovery of novel therapies for the treatment and prevention of ophthalmology diseases. Position Location Senior Clinical Research Associate Westcoast, USA Salary Reports to Highly competitive package, commensurate with experience Medical Director Responsibilities 1) Prepare and execute one or more clinical investigations (including pre-study, initiation, interim and close-out visits) 2) Monitor (completion of monitoring confirmation visit letters, trip reports, follow-up letters and study site payments) and also co-monitor and audit the work of others 3) Participate in investigator site selection 4) Coordinate vendor/CRO services 5) Initiate, review and negotiate site budgets/contracts 6) Participate in as well handle tasks related to organizing a sponsor and investigator meeting 7) Review, revise and develops SOPs 8) Schedule and perform the monitoring of one or more clinical investigational sites 9) Design/prepare case report forms 10) Generate study specific monitoring plans and informed consent templates 11) Prepare clinical study supplies to be shipped to investigational sites 12) Project the usage of clinical supplies 13) Register patients onto clinical investigations 14) Interact daily with appropriate individuals, departments or contractors to support and maintain the 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 case report forms 17) Document and maintain all site contacts on appropriate forms 18) Review tables, listings and study reports for assigned protocols 19) Monitor assigned protocols and/or projects 20) Participate in clinical team meetings, lead discussions on assigned protocols 21) Follow company SOPs, GCPs and ICH guidelines 22) Review literature 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) Degree in Nursing (R. N. or B. S. N), Life Sciences (B. S. or B. A.), Pharmacy or Medicine 2) Minimum 5 years of progressively increasing clinical research experience within the pharmaceutical industry 3) Experience in a small biotech environment preferred 4) Experience in preparation, organization and administration of early-stage (Phase I or small Stage II) clinical trials 5) Experience in working with orally available drugs 6) Experience in ophthalmology highly preferred 7) Experience in drug development, especially FDA regulations and GCPs or Associates of Clinical Pharmacology CRA certification 8) Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems under supervision 9) Ability to prepare summary reports and deliver presentations, which are clear and concise 10) Willingness to relocate to Seattle