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Job #02639

About our client Our client is a leading privately held pharmaceutical company with operations in over 40 countries. With marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Senior Clinical Research Associate New Jersey Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Participate in planning study implementation with departmental managers 2) Review protocols to become familiar with the details of single and multi-center research studies 3) Participate in protocol development and Case-Report Form (CRF) design (as assigned) 4) Communicate with study personnel to confirm and clarify protocol guidelines 5) Utilize the internal investigator lists and externally published sources to contact potential investigators 6) Review basic protocol information with the investigators and solicit necessary information 7) Perform initial evaluation of site’s eligibility for study 8) Travel to study sites to perform evaluation of the sites' eligibility for study participation 9) Enlist investigators (as appropriate) 10) Discuss details of study budgets with investigators and ensure that contracts are properly executed before initiation of studies 11) Prepare and present protocol and general study-related presentations at investigator meetings 12) Ensure that investigators are adequately informed of protocol requirements, Standard Operating Procedures (SOPs) and monitoring procedures 13) Travel to study sites on an ongoing basis to monitor progress of studies 14) Collect, review and correct Case Report Forms (CRFs) in accordance with study specific timelines 15) Monitor progress of patient enrollments and other benchmarks to assess ongoing progress and adherence to the study protocol by the investigator sites 16) Prepare monthly Investigator Status Report for Clinical Research Manager 17) Maintain study files by reviewing and archiving critical documents such as IRB approvals, FDA 1572 and adverse experience forms as well as all study-related correspondence 18) Perform other technical and administrative duties as reasonably assigned by the Clinical Research Manager Requirements 1) Bachelor's degree in a scientific discipline 2) 6+ years of clinical trial experience in the pharmaceutical or biotech industry 3) Minimum 4 years of experience in clinical research (at least 1 year in project management) 4) Experience in handling the management of a CRO 5) Experience in monitoring clinical trial from qualification to closeout 6) Strong knowledge and understanding of FDA regulations and GCPs 7) Exceptional communication skills 8) Willingness to travel – up to 70%