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Job #03020

About our client Our client is a rapidly growing pharmaceutical company headquartered in Northern California that is focused on the development and commercialization of various oncology therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Senior Clinical Research Associate Emeryville, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Synchronize the activities associated with the evaluation, initiation, management and closeout of clinical trials within the Clinical Development Department 2) Work with the Clinical Operations Team to identify clinical infrastructure gaps as well as develop systems and processes for addressing the gaps 3) Identify, select and monitor investigational sites for clinical studies 4) Ensure studies are carried out as per study protocol, SOPs and ICH/GCP regulations 5) Track progress of study including patient enrollment and monitor visits 6) Investigate queries and monitor discrepancies 7) Manage site conduct as well as the investigational product accountability and reconciliation process 8) Manage the budget and payments for investigative sites and contract organizations 9) Design and administer Case Report Forms 10) Write or contribute to preparation of clinical protocols, amendments, consent forms, study guides, CRFs and any other clinical research-related documents 11) Develop queries for data analysis 12) Negotiate and finalize Investigator budgets 13) Review data listings and summary tables including query generation 14) Oversee performance of CROs and field CRAs to ensure compliance with study protocol 15) Monitor (jointly) sites with field CRAs 16) Train CRAs on protocols and practices consistent with company and GCP standards 17) Assist in identifying and hiring appropriate CROs and study vendors 18) Generate and/or review relevant sections of clinical study reports, IND annual reports and Investigator brochures 19) Collaborate with CRAs and directors to identify Clinical Operations’ process needs 20) Work with Manager to identify/develop processes and procedures for enhancing department’s efficiency 21) Develop plans for implementing departmental infrastructure enhancements 22) Conduct SOP gap analysis and oversee preparation of new or modified clinical operation SOPs Requirements 1) Bachelor’s degree in a scientific discipline or equivalent 2) Minimum 5 years directly related experience in overseeing clinical trials 3) 2 – 3 years of monitoring experience 4) Oncology experience preferred 5) Experience in administering site budgets and grants 6) Experience in supervising and reviewing adequacy of site-proposed informed consents for compliance with relevant regulations 7) Knowledge of GCP/ICH guidelines and an understanding of regulatory requirements 8) In-depth knowledge of monitoring procedures 9) Understanding of concepts and practices for clinical trial conduct 10) Knowledge of FDA regulations and GCP 11) Ability to work independently and exercise good judgment in planning and accomplishing goals 12) Superb communication skills (oral and written) 13) Good organizational and planning skills 14) Ability to deal with time demands, incomplete information or unexpected events 15) Ability to work effectively in a team/matrix environment 16) Proficient in computers 17) Willingness to travel (up to 40%)