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Job #03487

About our client Our client is privately owned pharma company headquartered in New York that is focused on the development and commercialization of generic prescription, OTC and dermatology products. The company has an experienced management team, a robust line of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Project Leader New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Liase with CRO and clinical sites to monitor study progress. 2) To ensure the timely progression of an assigned project and the implementation of project-related decisions. 3) To maintain the flow of information to all concerned parties. Duties entail acting as the primary liaison between the Trial Team and other company departments (i.e. Regulatory Affairs, Planning, etc.) with respect to trial-related activities and external clients. Duties also entail attending internal project team meetings and generating internal and external correspondence. 4) To compose study documents as described in all relevant SOPs and/or dictated by Clinical Trial Manager (CTM). (May include, e.g. site selection questionnaire, Monitoring Plan, Communications Plan, Clinical Management Plan, etc.). 5) To ensure the compilation of monthly progress reports for a given trial and communicate trial-related progress to the CTM. 6) To ensure that a trial is properly monitored, in accordance with GCP, FDA regulations, all applicable SOPs, and the Monitoring Plan. 7) To organize the Investigator Meeting, start-up activities, reports and document submission. 8) Maintain trial tracking spreadsheets, including enrollment, monitoring visit schedules, document tracking, tracking of drug and CRFs, etc. 9) Collect regulatory documents, maintain project files and conduct administrative duties. 10) Assist in the compilation of monthly progress reports from CROs and review incoming monitoring and enrollment reports. 11) Audit of CROs and Investigative sites (as needed), including periodic co-monitoring. 12) Facilitate new systems developed by CTM. 13) Promptly forward SAE reports from clinical studies to Regulatory Affairs for regulatory submission. 14) Follow-up with CROs and/or investigators for additional information on SAEs and request hospital records, when necessary. 15) Prepare and distribute safety update letters to investigators as requested by Regulatory Affairs. 16) Serve as the primary contact for site and CRO personnel for selected projects. 17) Participate in study development and startup process including; design and/or review Case Report Forms; develop Case Report Form completion specifications. 18) Contribute to the preparation of documents for submission to regulatory authorities including protocols and final study reports. 19) Supervise project specific performance of external contractors including contract research organizations. Requirements 1) Minimum requirements include a Bachelor degree in a scientific discipline or health care discipline, plus 3-5 years experience in clinical research. 2) Prior experience, at least 2 years, as a Clinical Research Associate mandatory. 3) Demonstrated ability to work both independently and in a team setting and exhibit initiative. 4) Excellent verbal and written communication skills required. 5) Computer Literacy is required. Superior organizational skills and very detailed oriented. Travel: 20-25%.