Clinical Research Associate - Egypt

24-03-2021

Title: Clinical Research Associate
Location: Egypt

Qualifications

  • More than 1 year monitoring experience

 

Job Description:

 

  1. Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  2. Site selection and qualification evaluation.
  3. Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
  4. Collect all ECs requirements per allocated studies
  5. Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  6. Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance.
  7. Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  8. Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  9. Ensuring the study is conducted in accordance with international and national regulatory requirements Protocol and applicable Quality Document (SOPs, WI, Plan, Manual, etc).
  10. Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company and coordinating study materials distribution via depot or directly to sites.
  11. Providing any requested internal progress reports and completion of the relevant files.
  12. Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
  13. First line of communication for any study related issues arisen by sites for studies lead by him/ her.
  14. Execute any activities in compliance with applicable SOPs, instructions and principles.
  15. Responsible for issues escalation following the proper escalation pathway
  16. Act as a guide for juniors if needed.

    If interested, please send your CV to jobs@clinart.net mentioning the Job Title in the subject

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