Thermo Fisher Scientific

Senior Clinical Research Associate, Sr CRA

Thermo Fisher Scientific

full-time

Posted on:

Location Type: Remote

Location: Egypt

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Conduct on-site or remote visits to assess protocol and regulatory compliance
  • Manage procedures and guidelines from different sponsors and/or monitoring environments
  • Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines
  • Ensure audit readiness and develop collaborative relationships with investigational sites
  • Provide guidance and mentorship to junior CRAs
  • Support the Clinical Operations team in the region with the CRO setup
  • Monitors investigator sites with a risk-based monitoring approach
  • Ensure data accuracy through SDR, SDV and CRF review as applicable
  • Document observations in reports and letters in a timely manner
  • Ensure trial close out and retrieval of trial materials

Requirements

  • Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent
  • Proven experience in clinical research, with a minimum of 5 years of experience as a CRA
  • Comprehensive knowledge of ICH-GCP guidelines and regulatory requirements
  • Strong analytical skills and attention to detail to determine and address any discrepancies
  • Outstanding communication and organizational skills to prioritize effectively
  • Ability to work independently and as part of a collaborative team
  • Valid driver's license
  • Fluent in Arabic and English.
Benefits
  • Health insurance
  • Flexible working arrangements
  • Professional development opportunities
  • Paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchprotocol complianceregulatory compliancerisk-based monitoringdata accuracySDRSDVCRF reviewaudit readinessCRO setup
Soft Skills
analytical skillsattention to detailcommunication skillsorganizational skillscollaborative team workindependencementorship
Certifications
Bachelor's degree in life scienceRegistered Nursing certification