Note: The job is a remote job and is open to candidates in USA. Merck is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. They are seeking a highly skilled Clinical Research Associate to lead performance and compliance for assigned protocols and sites, ensuring adherence to regulations and contributing to the expansion of clinical research territory.
Responsibilities
- Build and sustain strong relationships with investigative sites across all trial phases
- Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents
- Develop deep understanding of study protocols and procedures
- Coordinate cross-functional tasks to achieve Site Ready status
- Participate in site selection and validation; provide informed input to decisions
- Conduct remote and on-site monitoring to ensure:
- Data integrity (complete, accurate, unbiased)
- Protection of subjects’ rights, safety, and well-being
- Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner
- Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out
- Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance
- Identify, assess, and resolve site performance, quality, or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD
- Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities)
- Maintain accurate, timely documentation in CTMS, eTMF, and other systems
- Act as a process SME: share best practices, drive continuous improvement, and deliver training
- Support and/or lead audit/inspection activities
- Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities
- Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate
Skills
- Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively
- Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks
- Demonstrated mentoring and leadership capability
- Hands-on knowledge of Good Documentation Practices
- Proven site management expertise, including independent oversight of site performance and patient recruitment
- High-level monitoring skills with sound, independent professional judgment
- Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools
- Ability to interpret data/metrics and take appropriate action, including in virtual settings
- Experience conducting site motivation visits to boost enrollment
- Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions
- Ability to mentor junior CRAs and perform co-monitoring visits
- Excellent time management, organization, interpersonal skills, conflict management, and problem solving
- High independence across multiple protocols, sites, and therapy areas
- Strong sense of accountability and urgency; able to prioritize and multitask in changing environments
- Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships
- Customer-focused mindset with high standards of quality and compliance
- Positive, growth-oriented, self-driven, and professional demeanor aligned with company values
- Bachelor's degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO
- Accountability
- Adaptability
- Adverse Event Reporting System
- Clinical Research Methods
- Clinical Site Management
- Clinical Study Management
- Clinical Trials Monitoring
- Good Clinical Data Management Practice (GCDMP)
- Good Clinical Practice (GCP)
- Protocol Adherence
Benefits
- Opportunity to shape clinical research at high-performing sites and contribute to global development programs.
- A collaborative environment with growth, mentorship, and continuous improvement.
- Competitive compensation and benefits.
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