Study Startup Specialist - Egypt

03-07-2021

Title: Study Startup Specialist
Location: Egypt

 Qualifications:

  • Must be based in Egypt.
  • Minimum 1- 2 years’ experience in the clinical research field.
  • “CVs that doesn’t fulfill the criteria will be discarded.”

Job Description:

  • Assist/advise project teams on all regulatory requirements for clinical studies, Update all the departments in case of any update on the regulatory requirements.
  • Create and maintain regulatory database for all the countries including the most up to date regulations and the documents needed for submission.
  • Perform compliance assessments if needed for regulatory packages according to country requirements and document any activity discovered; notify Project Managers of any findings.
  • Review and adapt study specific documents according each country and site requirements.
  • Perform IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirements.
  • Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with Clinart or Sponsor SOPs.
  • Receive and process study documentation from sites, check content and quality as well as completeness.
  • Interact with site personnel, , CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review.
  • Provide Project teams with accurate periodic status reports about the conducted and the planned submissions.
  • Attend internal and external project meetings as needed.
  • Respond to Decision Letters from IRB/EC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements.
  • Adapt Informed Consent Form (ICF) according to RA/IRB/EC requests on country or site level.
  • Compiling and assessing completeness of the Regulatory-Package for drug release.
  • Assist with QC and QA of various study related Regulatory documents and reports when needed or in case of audit preparation.
  • Oversee translation of regulatory documents, if needed, on behalf of Sponsor.
  • Manage sites budgets and sites contracts , depending from Countries/Regions in collaboration with the PM/CRA.
  • Responsible for conducting feasibility studies in countries as shared by the BD, operations.
  • Responsible to create and maintain investigator’s database based on the feasibility activities in all Clinart countries.

 

 

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

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