Senior Clinical Research Associate

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November 20

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WEP Clinical

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Pharmaceuticals • Healthcare Insurance • Biotechnology

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

51 - 200 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Perform and coordinate all aspects of clinical monitoring and site management in compliance with ICH Good Clinical Practice (GCP), FDA/MHRA/EMA guidelines, local regulations, and WEP Clinical Standard Operating Procedures (SOPs). • Conduct on-site and/or remote monitoring visits to assess site adherence to protocol and regulatory requirements. • Manage essential documentation, ensuring that patient and site data remain inspection-ready for WEP Clinical, Sponsors, and regulatory agencies. • Develop and maintain strong relationships with sponsors and clinical sites, serving as a trusted point of contact throughout the study's lifecycle. • Contribute to developing study-specific procedures and documents, such as the Clinical Monitoring Plan. • Train and coordinate other CRAs within the clinical monitoring team.

🎯 Requirements

• 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%.

🏖️ Benefits

• Private healthcare insurance • Long-term illness Cover • Death in service cover • Salary sacrifice pension • Annual leave • Paid maternity & paternity leave • Volunteer day