This Clinical Research Associate role focuses on leading performance and compliance for assigned protocols and sites within the South East, serving as the primary site contact throughout all phases of clinical studies. The position involves ensuring rigorous adherence to ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.
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) and 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
Requirements
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
Millions of jobs, with real people getting hired every day
200,000+
New jobs added daily
7,000,000+
Verified job listings
1,000,000+
Tailored applications submitted
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
Nice to have:
Valid driver’s license (required in certain countries)
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
Important Details
Travel: Approximately 65–75% (about 2–3 days per week, domestic and international)
Application deadline: 7 November 2026
Application Process
Submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements
About the Company
Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core. The company is also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
