New job Record Specialist - 2 openings – 4 month contract (New Jersey) *Current U.S. work permit status required. No VISA sponsorship provided*

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Group: Job Openings, Job Leads and Job Connections! Subject: Record Specialist - 2 openings – 4 month contract (New Jersey) *Current U.S. work permit status required. No VISA sponsorship provided* Margaret Imperiale posted a job: Record Specialist - 2 openings – 4 month contract (New Jersey) *Current U.S. work permit status required. No VISA sponsorship provided* "To view this and other current positions please visit www.JGBBioPharma.com. Interested parties should contact Nicole@JGBBioPharma.com. The Record Specialist is responsible for preparing: • Filling and archiving of clinical trial documents including CRFs and all documents related to the Clinical Trial Master File (TMF) • CRF and related clinical documents for submission • CD roms for the investigator study file • Works in strong collaboration with Record Coordinator and T.O staff. Major Duties/Responsibilities: • Work in close collaboration with Trial Operations teams to provide services for trial Record management, from study set-up to closure. These records include CRFs and all documents for the clinical trial master file. • Perform daily tasks associated with initial receipt and quality control of clinical trial documents for filling and archiving. • Involved in the preparation of the Clinical Study Report (CSR) appendices into the document repository system. • Assist in the preparation and QC of documents for submission to regulatory agencies. • Perform the data entry in archiving tools for the tracking of all documents • Perform QC and all supportive activities on the preparation of CD rom for the Investigator Study File. • Communicate effectively with study teams. EXPERIENCE AND QUALIFICATIONS: • High attention to detail and accuracy • Understands the clinical development process and GCP's • Consistently meets deadlines according to accepted levels of quality • Ability to follow guidelines precisely and to follow through on all tasks • Provides high quality results • Familiarity with Windows-based computer applications (e.g., MS EXCEL, ACCESS and Powerpoint) • Detail-oriented and good organizational skills • Ability to work effectively in a team • Effective written and oral communication in English, and interpersonal skills • High school diploma or equivalent. • A minimum of 3 years experience in pharmaceutical industry or clinical-related discipline Familiarity with medical terminology, general understanding of the R&D process and previous exposure to GCPs/ICH is required. I have these openings in case you can think of anyone who might be interested: FTE positions (San Francisco Bay area): Process Development (Assoc Dir to Sr Director level) CMC Quality (Sr) Manager (Senior) Medical Director Safety & Clinical; Clinical Manager; SCRA/ Clinical Manager (Senior) GCP QA Manger; Clinical Manager / Associate Director Marketing Communications Manager Sr Data Manager Medical Writer Senior Device Engineering Manufacturing Assoc Director/Director CMC Regulatory Manager/ Sr Manager Regulatory Statistical Programmer Sr RA/ Associate Scientist Nonclinical Director Medical Communications Director Medical Affairs And these contract openings in the (San Francisco Bay area): Project Manager (BLA/ NDA submission experience desired) Medical Director Oncology (20-40 hr/ wk for 6 mths) Medical Affairs Writer (Must have Med Aff experience) Statistical Programmer (3 d/wk; some work onsite/ some remote) GCP Consultant (40 hr/mth) Positions in Pacific Northwest: Project Coordinator CMC We have other contract positions open in NJ, Boston, and PA. See www.JGBBioPharma.com/JOBS for full job descriptions Margaret Imperiale, Administrative Services www.JGBBioPharma.com"

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