Senior Clinical Research Associate – Client Dedicated

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 and manage required documentation. • Manage procedures and guidelines from different sponsors and monitoring environments. • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs. • Ensure audit readiness and develop collaborative 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 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, root cause analysis, critical thinking, and problem-solving. • Ensure data accuracy through SDR, SDV, and CRF review. • Assess investigational product inventory and records. • Document observations in reports and letters and escalate deficiencies through resolution. • Maintain contact with investigative sites between monitoring visits. • Participate in investigator payments and investigator meetings. • Identify and initiate qualified investigative sites. • Ensure trial closeout, retrieval of trial materials, and completion of essential documents. • Mentor new team members and assist with project publications, tools, and training. • Identify process improvements and share solutions. • Provide trial status tracking and progress reports to the Clinical Lead. • Update CTMS and perform required quality-control checks. • Facilitate communication between sites, the client company, and the project team. • Respond to company, client, and regulatory audits and inspections. • Complete administrative tasks such as 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. • Minimum of 5 years of experience as a clinical research monitor/CRA. • 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 collaboratively. • Valid driver's license. • Fluent in Arabic and English.

🏖️ Benefits

• Fully remote work arrangement • Opportunity to contribute to groundbreaking research and support scientific advancements • Collaborative global team environment • Diverse perspectives and inclusion • Reasonable accommodation for individuals with disabilities • Equal employment opportunity