Senior Clinical Research Associate – Client-dedicated FSP

🕒 September 10

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 22%

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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 clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Team Manager • Update and perform quality control checks on clinical trial management systems • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make recommendations regarding site acceptability • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, newsletters, trip report reviews, and CRA team calls • Facilitate communication between investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 2+ years of experience as a clinical research monitor • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Valid full driver's licence • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application of ICH GCPs, applicable regulations and procedural documents • Risk Based Monitoring knowledge • Root cause analysis and problem-solving skills • Effective oral and written communication skills • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficient knowledge of Microsoft Office and ability to learn appropriate software • Good Dutch, French and English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements • Ability to travel frequently, generally 60–80%, including possible extended overnight stays

🏖️ Benefits

• Fully remote work option in Belgium • Hybrid/office-based work option from the Brussels site • Client-dedicated FSP team environment • Opportunities to contribute to project publications, tools, process improvement, and other initiatives

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