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Clinical Research Associate

Jobot Blacksburg, VA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Clinical Research Associate

This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $65,000 - $90,000 per year

A bit about us:



Based in Blacksburg VA, we are a biotech startup developing an oral first-in-class therapeutics designed to target autoimmune diseases. We are looking for a Clinical Research Associate to join our growing team!

Why join us?


  • Competitive Salary!
  • Extremely Competitive Benefits Package
  • Adaptable/Flexible Schedule!


Job Details


  • Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. - Requires travel to be physically on location to conduct site visit.
  • Responsible for multiple projects and must work both independently and in a team environment.
  • Participates in the study development and start up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings.
  • Works with management on monitoring strategy.
  • Track items related to CDAs, budget and contract completion status.
  • Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
  • Perform clinical data review of data listings and summary tables, including query generation.
  • Creating and writing trial protocols, and presenting these to the steering committee.

Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
  • Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
  • Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing inventory, and reconciliation.
  • Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
  • Conducting regular site visits, coordinating project meetings, and writing visit reports.
  • Implementing action plans for sites not meeting expectations.
  • Liaising with regulatory authorities.
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.


Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Jobot

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Address

Blacksburg, VA
USA

Industry

Healthcare

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