Note: The job is a remote job and is open to candidates in USA. WEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. They are seeking a Senior Clinical Research Associate to oversee clinical monitoring and site management, ensuring compliance with regulatory requirements and building strong relationships with sponsors and sites.
Responsibilities
- 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
Skills
- 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
- Cell and Gene Therapy Experience Required
Benefits
- Medical, dental, and vision insurance
- FSA, HSA
- Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
- Group short-term and long-term disability insurance
- Group Life Insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday, sick and volunteer time
- Paid maternity & paternity leave
Company Overview
WEP Clinical is a specialist pharma services company that works with drug developers. It was founded in 2008, and is headquartered in Morrisville, North Carolina, USA, with a workforce of 201-500 employees. Its website is http://www.wepclinical.com.