Title: Study Startup Specialist
- 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.”
- 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 firstname.lastname@example.org mentioning the Job Title in the subject