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Clinical Scientist: MedFocus
    CLINICAL SCIENTIST
COMPANY INFO: MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel. Our client is dedicated to discovering and developing new medicines that improve the lives of people with inflammatory or viral disease and is seeking to add a Clinical Scientist to their team in Palo Alto, California. RESPONSIBILITIES: • Assists the clinical science leader, clinical scientists and clinical science specialists overall study management, evaluation and documentation. • Participates in the ongoing science/medical review and cleaning of study data • Participates in SAE report process according to SOP's • Participates in reconciliation of clinical and safety databases • Assists in narrative writing for SAEs for Clinical Study Reports • Assists in establishing glossaries, review and provide input for database conventions, edit checks, data displays, and case report form summaries • Participate in the review and organization of data for final study reports • Assist in providing response to regulatory agency questions and preparation of advisory committee meetings • Assists in coordinating, preparing, and reviewing study results • Assists in quality and timely preparation and review of all relevant documents • Participates in routine review of laboratory results and ensuring appropriate follow-up for pre-defined safety parameters • Assists in routine writing of narratives for SAEs and other events as requested • Participates in ongoing review of efficacy and safety outputs and query information as appropriate • Assists in ensuring correct data interpretation including interim and Final Study Reports before they are approved • Task priorities and schedules within a project as well as time schedule in view of the next assessment points for projects • Assists in assuring that the SOPs for evaluation, documentation and reporting of SAEs are strictly followed within PDCV and together with PDS assesses the etiology/causality of SAEs and laboratory abnormalities • Attends appropriate orientation and training for employees QUALIFICATIONS: • MD or DO preferred; PharmD, PhD, RN or equivalent scientific/medical qualification minimal with clinical experience preferred, therapeutic area experience a plus • Two to Five years Industry experienced, particularly in Clinical development and Drug safety • Fluent in English MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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