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Job #02409

About our client Our client is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. The company, founded in late '80s, has strength of 85 people. They are located in New Jersey, Washington, Edmonton, Arizona and Texas. Their goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. Position Location Clinical Research Associate (Office-Based) Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist in managing all aspects of clinical studies 2) Ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines 3) Plan, implement, monitor and manage clinical trials 4) Assist with the operations of the clinical department (e.g. review/revise SOPs, develop databases, initiate contracts, review and negotiate clinical site budgets, train staff) 5) Provide supervision and guidance, clinical trial management expertise and direction to in-house and contract CRAs and CROs 6) Analyze/report safety issues, patient care issues, and study design and/or study conduct issues 7) Participate in the design and development of clinical trial protocols and case report forms 8) Assist in the preparation of clinical study reports and annual reports 9) Oversee drug accountability at investigator sites and assist with the projection and management of clinical supplies 10) Assist in preparing study budgets and timelines Requirements 1) 5+ years of relevant experience 2) Minimum 3 years of experience as a CRA in a pharmaceutical company 3) Experience in oncology vaccines preferred 4) Knowledge of FDA regulatory requirements and ICH/GCP guidelines 5) Ability to work independently and in a team environment 6) Demonstrated proficiency in the implementation, monitoring and management of clinical trials 7) Ability to prioritize and handle multiple tasks simultaneously 8) Dedication to quality and reliability in all work tasks 9) Self-motivated with an eagerness to grow professionally and commitment to self-development 10) Computer proficiency (PC-Windows preferred) 11) Excellent communication skill 12) Strong organizational skills 13) Willingness to travel both nationally and internationally – up to 50%