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CRA I

Knoxville
Permanent
Reference: JR065549
This vacancy has now expired.
Description

As a Clinical Research Associate I at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - III, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

  • At least 12 months experience as an independent monitor
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 60%) domestic and/or international.
  • Familiarity with ICON's SOPs/WPs, ICH-GCP and appropriate regulations
  • Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
  • Familiarity with principles of investigator recruitment.
  • Assist with coordinating all the necessary activities required to set up and monitor a study, including the following identifying investigators.
  • Help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.
  • Coordinate documents translation, verification and back translations where required.
  • Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
  • Pre-study/placement and initiation visits.
  • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP as appropriate.
  • Maintain all files and documentation pertaining to studies.
  • Motivate investigators in order to achieve recruitment targets.
  • Complete accurate study status reports.
    Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
  • Keep the Project Manager regularly informed.
  • Process case record forms to the required quality standards and timelines .
  • Deal with sponsor generated queries in a timely manner.
  • Ensure the satisfactory close-out of investigator sites.
  • Ensure correct archiving of files on completion of a study.
  • Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits.
  • Participate in feasibility studies for new proposals, as required
  • Maintain patient and sponsor confidentiality .
  • lnvestigational Products (IPs) stored and managed by the site
  • Ensure storage conditions and acceptable supplies are provided
  • Ensure IPs are supplied only to eligible patients Ensure IP receipt, use and return are controlled and documented
  • Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
  • To participate, if requested, in the preparation of and review of study documentation e.g., draft protocols, draft CRFs, monitoring guidelines and elements of final report.
  • Participate in data listing reviews, as applicable.
  • Assist with marketing the company if and when appropriate.
 

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