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Clinical Research Associate

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Prowess IT Solutions LLC

2021-12-03 13:00:03

Job location East Brunswick, New Jersey, United States

Job type: fulltime

Job industry: Science & Technology

Job description

Clinical Research Associate needed w/ Master's deg. or Foreign Equiv in Pharmaceutical Sciences or Pharmacology or Pharmacy & 1 yr exp as Clinical Research Associate or Functional Informaticist performing following job duties or Bachelor's Deg. or Foreign Equiv in Pharmaceutical Sciences or Pharmacology or Pharmacy & 5 yrs of progressive work exp as Clinical Research Associate or Functional Informaticist performing following job duties: Conduct Pre-study, Site Initiation, Routine Monitoring & Close-out Visits by GCP & ICH guidelines, study protocols, study rltd plans & applicable federal, local & co. SOPs. Support activities for study start-up from CDAs, feasibility questionnaire & feedback, PSVs, regulatory docs. collection & submission to IRBs, contract & budget rltd follow-ups, trackers, templates, plans & SIVs. Provide resources to sites on the study protocol, study rltd tools, systems, CRF completion guidelines & data mgmt expectations. Support selection of potential investigators, prep'n of EC submissions, notifications to regulatory authorities, scheduling of meetings & other tasks as appropriate. Ensure, contribute & address any items in data qlty, safety meetings or clinical trial/study meetings. Assure timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) & protocol violations. Update CTMS systems for site rltd info or any other info as req'd. Mail Resumes to: Prowess IT Solutions LLC, 2 Brier Hill Ct, 2B Bldg F, East Brunswick, NJ 08816. Job Locs.: East Brunswick, NJ or unanticipated client sites w/in U.S. Must be available to travel & relocate to client sites for temp. projects.
recblid 8x79hmscgla4j9tc4gmxe5awo5xwzo

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