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Job #02505

About our client Our client is a trial management company that provides specialized clinical study and project management services to the pharmaceutical industry. The company independently manages the entire clinical study or a portion of it without the high costs associated with outsourcing. Position Location Senior Clinical Research Associate New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the DCM with day-to-day management functions of the clinical monitoring team 2) Monitor in-house clinical trials 3) Review trial data 4) Prepare electronic CRFs 5) Oversee CRA monthly calendars 6) Create/update CRA training logs 7) Create/update short CVs 8) Pre-screen all CRA candidates 9) Create/update CRA CV database 10) Schedule CRA interviews 11) Assist the DCM in the development/revision of SOPs and policies/procedures as they relate to the Clinical Monitoring Team 12) Assist with organizing/implementing CRA regional meetings and training programs under the direction of the DCM 13) Liaise between the field CRAs and the study managers/in-house CRAs 14) Work with the in-house CRA to confirm that all reports/letters are received in-house in a timely manner 15) Support the study managers as needed with monitoring tasks/data review/retrieval Requirements 1) Bachelor’s degree in Nursing preferred 2) 3+ years of clinical trial experience in the pharmaceutical or biotech industry 3) 5 years of Regional CRA experience 4) Lead CRA experience preferred 5) Experience with EDC 6) Management experience a plus 7) Experience in preparing and submitting electronic CRFs 8) Experience in reviewing data 9) Experience in urology or women’s health 10) Strong knowledge and understanding of FDA regulations and GCPs 11) Detail-oriented 12) Exceptional communication skills 13) Flexible and willing to adapt to company changes 14) Willingness to travel (once a month)