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Study Coordinator II

Company: Labcorp
Location: Somerset
Posted on: July 23, 2021

Job Description:

Job Overview:

Labcorp Drug Development is currently hiring for a Study Coordinator II to join our growing team in Somerset, New Jersey.

 

Responsibilities include (but are not limited to):

  • Provides administrative and scientific support for toxicology studies, including prestudy tasks (e.g., protocol development, costing, scheduling), monitoring the inlife progress of assigned studies, and interacting with clients.
  • Provides administrative backup support for Study Directors on day to day study-specific activities or tasks.
  • Learns to ensure study compliance with the protocol, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines.
  • Learns to coordinate the study award process as applicable
  • Learns to coordinate the efforts of a study team to become a successful project manager.
  • Learns to plan, prioritize, and manage a workload and the associated responsibilities.
  • Serves as a contact, along with the Study Director, in communication and interactions with other departments and clients, with assistance as applicable.
  • Learns to maintain complete, organized, and current study files including study schedule, protocol, and applicable correspondence.
  • Learns to draft protocols and amendments for Study Director Review and approval.
  • Ensures all client comments on protocols and amendments are addressed in a timely manner.
  • Initiates and submits costing and scheduling requests with assistance.
  • Schedules and participates in preinitiation and other study-related meetings, as required, and takes and distributes preinitiation meeting minutes.
  • Learns to draft and submit appropriate documents to the IACUC/AWERB for approval.
  • Verifies the project schedule accurately reflects the requirements of the protocol.
  • Learns to monitor progress and status of assigned studies with assistance.
  • Learns to review data and identify deficiencies.
  • Learns to compile data for clients for regular study progress updates.
  • Learns to address and review quality assurance audits relating to protocols and amendments and reports (as applicable), with oversight. Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines.
  • Assists with hosting client visits.
  • Learns to perform QC (peer) reviews on study reports.
  • Undertakes other administrative or scientific duties as assigned.
  • Learns to use project tracking systems, as appropriate
  • Learns to assist the Study Director in monitoring the financial status of ongoing studies, including completion of work scope changes as applicable.
  • Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place
  • May assist with the preparation (with guidance) CTD tables
  • Prepare shipping documentation including CITES application requests and any other associated shipping documentation, as required per study

Education/Qualifications:

BA/BS in Biological Sciences.  Excellent Computer skills (Word, Excel, Powerpoint).

Experience:

Previous GLP Regulated Toxicology experience. 

Keywords: Labcorp, Trenton , Study Coordinator II, Other , Somerset, New Jersey

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