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Job #03218

About our client Our client is a start-up biotech firm based in Concord, California. They focus on developing immune-based therapies for cancer and infectious diseases. They are seeking a Senior Clinical Research Associate to join their growing team. This is an excellent opportunity for someone looking to work in a fast-paced environment. Position Location Senior Clinical Research Associate Concord, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage operational activities pertaining to the execution of early-phase clinical trials including day-to-day interactions with CROs, vendors, consultants and clinical sites (as necessary) 2) Contribute to the development of study timelines and budgets in conjunction with the management 3) Maintain systems for tracking study progress in order to provide updates to management as well as to ensure continued compliance with SOPs and applicable regulations 4) Work effectively with team members (including CROs and vendors) to successfully accomplish study objectives 5) Develop study documents including study reference manuals, pharmacy binders and CRFs 6) Prepare, collect and track required regulatory documentation from clinical sites 7) Manage the monitoring of clinical studies including occasional site monitoring and/or co-monitoring 8) Review monitoring reports, track study invoices (sites and vendors) and maintain study files 9) Participate in evaluating/selecting new investigators and vendors such as central laboratory services and CROs 10) Coordinate the planning of site initiation visits, Investigator meetings and other study meetings (e.g. DSMB, SMC, etc.) 11) Liaise with the Medical Monitor to manage critical safety issues 12) Participate in developing database specifications 13) Edit specifications and electronic CRFs for web-based Electronic Data Capture (EDC) system 14) Work with the Biostatistician as well as programmers to develop data listings and tables to meet needs for analyses and internal data review 15) Make projections for as well as order and track clinical investigational drug and non-drug study supplies 16) Contribute to the development and maintenance of Clinical Department operations including the reviewing/creating SOPs Requirements 1) Bachelor’s degree 2) Minimum 4 years of industry experience with minimum 2 years in direct clinical trial monitoring (or equivalent combination of education and experience) 3) Experience in early-phase, oncology and/or ex-US clinical studies a plus 4) Knowledge of current GCP requirements and their application in conducting clinical studies in the US 5) Superb interpersonal and communication (written and oral) skills 6) Proficiency in MS Word, Excel and PowerPoint 7) Expertise in MS Project preferred 8) Ability to communicate effectively across different levels in the organization 9) Ability to work independently and manage time appropriately (timelines, schedules, task prioritization) 10) Well-organized with attention to detail/accuracy 11) Willingness to travel (up to 30%) within the US as well as abroad