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WEP Clinical

Specialist services for early access medicines

Senior Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in NetherlandsNo salary listed

About the Job

Requirements

  • A bachelor's degree in life sciences, nursing, or a related field is preferred.
  • At least 5–7 years of experience conducting on-site and remote monitoring visits, or equivalent clinical research experience, is required.
  • Senior CRA leveling is described as SCRA I (3–5 years), independently managing complex sites, and SCRA II (5+ years), overseeing complex sites or regions, mentoring peers, and driving process improvements.
  • Broad therapeutic exposure across multiple study types and indications is required.
  • Strong technical and scientific aptitude, with the ability to quickly grasp and execute clinical protocols, is required.
  • Advanced organizational and logistical skills, including the ability to manage multiple sites and protocols within budget and timelines, are required.
  • Excellent written and verbal communication and confident stakeholder engagement are required.
  • A solid understanding of medical and therapeutic areas and medical terminology is required.
  • The ability to train, coach, and mentor clinical research staff is required.
  • Proficiency with Microsoft Office and electronic data capture systems is required.
  • Willingness to travel up to 80% is required.

Responsibilities

  • Oversee clinical monitoring and site management in compliance with Good Clinical Practice, global regulatory requirements, and company standard operating procedures.
  • Conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready.
  • Build relationships with sponsors and sites and serve as a key point of contact throughout the study.
  • Support development of study-specific procedures, such as monitoring plans, and assist in training or coordinating other clinical research associates.
  • Contribute to the design and review of study documents, including protocols, case report forms, informed consent forms, and study plans.
  • Lead site feasibility activities by distributing and collecting questionnaires, evaluating responses, conducting site qualification visits, and recommending sites for selection.
  • Plan and conduct site initiation visits, routine monitoring visits, and close-out visits in line with protocols, International Council for Harmonisation Good Clinical Practice, and regulatory requirements.
  • Build relationships with site staff and deliver training and ongoing guidance on protocol compliance and regulations.
  • Verify source data and case report forms for completeness, accuracy, and consistency, and keep site files audit-ready.
  • Review investigational product accountability, safety event documentation, and protocol deviations; drive corrective and preventive actions.
  • Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence.
  • Track and close action items within study or company timelines and maintain oversight of monitoring deliverables.
  • Support investigator meetings and key internal and external meetings; contribute to standard operating procedures, monitoring tools, and templates.
  • When assigned as Lead CRA, oversee monitoring on complex studies; develop study-specific monitoring documents, including clinical monitoring plans, deviation plans, and report templates; finalize visit reports; train and coordinate clinical research associates; serve as the primary clinical monitoring contact for the project manager and sponsor; and handle clinical research associate escalations.

About the Company

WEP Clinical

Specialist services for early access medicines

WEP Clinical provides access to unlicensed or scarce medicines through Expanded Access Programs (EAP) and Managed Access Programs (MAP) for healthcare providers in 60+ countries. It designs and runs these programs, coordinates with manufacturers and regulators, and sources medicines via a global network, with import authorizations and logistics handled by country managers and in-house pharmacists. Its approach combines global sourcing with local expertise and an end-to-end program model, differentiating it from others that rely on limited markets or suppliers. Its goal is to deliver needed treatments quickly when options are unavailable.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
2008

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