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WEP Clinical

Posted 3 months ago

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Senior Clinical Research Associate

Remote, USRemoteFull-time

AI Summary

A Senior Clinical Research Associate oversees clinical monitoring and site management, ensuring GCP and regulatory compliance while coordinating with sponsors, sites, and internal teams to support study execution and quality.

About this role

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Senior Clinical Research Associate (Senior CRA) oversees all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs. They conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready. The Senior CRA builds strong relationships with sponsors and sites, serving as a key point of contact throughout the study. They may also support development of study-specific procedures (e.g., Monitoring Plans) and assist in training or coordinating other CRAs.

The Ideal Candidate:

  • Leader
  • Detail Oriented
  • Problem Solver
  • Adaptable

    • What You'll Do:

  • Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans).
  • Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection.
  • Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements.
  • Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations.
  • Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready.
  • Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative 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; maintain clear oversight of monitoring deliverables.
  • Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates.
  • (Lead CRA, if assigned) Oversee monitoring on complex studies; develop study-specific monitoring documents (e.g., CMP, deviation plan, report templates); finalize visit reports; train/coordinate CRAs; act as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations.

    • What You'll Need:

  • Bachelor’s degree (life sciences, nursing, or related field preferred).
  • 5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience).
  • Senior CRA levelling: SCRA I (3–5 yrs) – independently manages complex sites; SCRA II (5+ yrs) – oversees complex sites/regions, mentors peers, and drives process improvements.
  • Broad therapeutic exposure across multiple study types and indications.
  • Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols.
  • Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines.
  • Excellent written and verbal communication; confident stakeholder engagement.
  • Solid understanding of medical/therapeutic areas and medical terminology.
  • Proven ability to train, coach, and mentor clinical research staff.
  • Proficient with MS Office and EDC systems; willing to travel up to 80%.
  • Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

    • Skills

    Clinical MonitoringData Query ManagementEDC SystemsGCPICH-GCPMicrosoft OfficeSite ManagementSIVSOPsSQV

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