Senior Clinical Research Associate – Sr CRA

🕒 April 4

🇪🇬 Egypt – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 55%

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🗣️🇸🇦 Arabic Required

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct on-site or remote visits to assess protocol and regulatory compliance • Manage required documentation, procedures, and sponsor/monitoring-environment guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure audit readiness and develop relationships with investigational sites and client personnel • Support CRO setup and obtain required licenses in the region • Advise study teams on feasibility, submissions, contract negotiations, and study startup activities • Customize monitoring plans, operational procedures, and tools for local regulations • Collaborate with cross-functional teams to implement study plans and resolve issues • Monitor investigator sites using risk-based monitoring, RCA, SDR, SDV, and CRF review • Assess investigational product inventory and records • Document and escalate deficiencies, track issues through resolution, and follow up on findings • Provide trend updates and strategy recommendations to the Clinical Lead • Participate in investigator meetings and identify and initiate qualified investigative sites • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Mentor junior CRAs and assist with training, publications, informed consents, CRF guidelines, and monitoring plans • Identify process improvements and share solutions • Provide trial status tracking and progress reports; update CTMS and perform required QC checks • Facilitate communication among investigative sites, client company, and PPD project team • Respond to company, client, and regulatory audits and inspections • Complete expense reports and timesheets

🎯 Requirements

• Bachelor's degree in a life science related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 5+ years of experience as a clinical research monitor/CRA • Proven experience in clinical research • Comprehensive knowledge of ICH-GCP guidelines and regulatory requirements • Strong analytical skills and attention to detail • Outstanding communication and organizational skills • Ability to work independently and as part of a collaborative team • Valid driver's license • Fluent in Arabic and English • Willingness/ability to work in Egypt • Equivalency of appropriate education, training and/or directly related experience may be considered

🏖️ Benefits

• Full-time employment • Fully remote work arrangement • Standard Monday–Friday work schedule

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