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Job #02887

About our client Our client is a biopharmaceutical company dedicated to the development and commercialization of therapeutics to treat patients with cancer and other life-threatening diseases. The company has an experienced management team, a strong pipeline and multiple products currently on the market. As a member of therapeutically aligned Clinical Study Management Team, the Senior Clinical Research Associate will be responsible for assisting in the planning, implementation, monitoring and management of clinical studies, maintaining the department’s central files. Position Location Senior Clinical Research Associate Northern New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee start-up of clinical trials 2) Manage development of trial related documents and operational procedures as well as regulatory document collection, and document filing 3) Handle protocol and CRF development as well as implementation 4) Manage clinical investigational site recruitment as well as negotiation of clinical trial agreements and grants 5) Handle pre-study site evaluations, clinical investigational site monitoring and closeout as well as clinical investigational site training 6) Supervise adverse event reporting 7) Ensure that data collected is accurate and verifiable 8) Handle resolution of clinical investigational site queries 9) Ensure drug shipments and accountability 10) Review site study files 11) Assist in the evaluation, selection and monitoring of CROs and other vendors based on the scope of work 12) Establish performance metrics for the trial and contribute to training of vendor staff (as appropriate) 13) Monitor/co-monitor (independently) multiple investigational sites for therapeutic areas, in accordance with state and federal regulations, GCPs and internal SOPs 14) Train and mentor junior level Clinical Research staff 15) Review (independently) SAE reports and clinical study reports with associated study tables, listing and figures Requirements 1) Bachelor's degree in Life Sciences (advanced degree a plus) 2) Minimum 5 years of clinical research experience with 3 – 4 years of direct monitoring experience 3) Excellent understanding of the clinical development process, GCPs and ICH guidelines 4) Knowledge of therapeutic areas (oncology, transplantation or immunology) 5) Proficient in MS Word, MS Project and Excel 6) Superb organizational and communication (verbal and written) skills 7) Excellent interpersonal skills 8) Willingness to travel – minimum 20% (domestically and/or internationally)