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Job #02990

About our client Our client, located in Northern California, is a biopharmaceutical company dedicated to discovering, developing and commercializing novel small molecule drugs to treat cancer. Position Location Clinical Research Associate Palo Alto, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate CRA site monitoring 2) Oversee field CRAs, assignments, data-monitoring schedules and quality of data capture 3) Coordinate the activities of CRAs (company employees as well as contract consultants) 4) Review site monitoring reports and act on queries/deficiencies 5) Answer or, as appropriate, manage data-related queries from site personnel, CRAs or database management personnel 6) Function as the key point of contact for CRO monitors 7) Arrange pre-study site visits and site-initiation visits 8) Review/QA pre-study site-visit reports against follow-up letters 9) Monitor sites 10) Organize clinical team routine monitoring visits 11) Review/QA routine monitoring-visit reports against follow-up letters and previous reports 12) Monitor clinical sites as per GCP requirements to supplement and/or QA the activities of the supervised CRAs 13) Liaise with sponsor and in-house CRAs in order to ensure site and CRO compliance with GCP guidelines 14) Support external QA/QC function for recurring themes 15) Review DMDQ plans 16) Serve as a member of the clinical research team in protocol designing and reviewing 17) Prepare and review CRFs and CRF Completion Guidelines 18) Review clinical study reports for identifying site-specific issues, completeness, accuracy, congruence with SOPs, congruence with previous and subsequent reports, congruence with relevant follow-up correspondence 19) Manage site closure activities 20) Conduct SAE and AE reconciliation process review with the Safety Pharmacovigilance Group 21) Manage updates in ICF, regulatory documents to investigators for submitting to IRBs Requirements 1) Bachelor's degree in a scientific discipline (BS/RN preferred) 2) Minimum 7 years of CRA experience including 4 years of field monitoring expertise 3) Experience in managing a clinical team including monitors with a sponsor company 4) Experience in assisting the management/coordinating Phase 2/Phase 3 studies 5) Experience in oncology or other complex therapeutic area highly preferred 6) Medical background and familiarity with medical diseases preferred