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. The Senior Clinical Research Associate will oversee clinical monitoring and site management, ensuring compliance with regulatory requirements and building relationships with sponsors and sites. This role involves conducting monitoring visits, training site staff, and managing study documentation to ensure protocol adherence.
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
- 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
- Bachelor's degree (life sciences, nursing, or related field preferred)
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