Senior Clinical Research Associate

Job description

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. ***Complex Study Experience Required*** ### 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