Clinical Research Associate

Merck Gruppe - MSD Sharp & Dohme; United Kingdom; Remote; GBP 40,000 - 65,000; Full time

Job summary

Merck & Co., Inc. in the UK is seeking a Clinical Research Associate to lead site monitoring and ensure ICH/GCP compliance across assigned trials.

You will build relationships with investigative sites and manage documentation in CTMS/eTMF, supporting audits and regulatory findings. The role requires travel of 65–75% (about 2–3 days per week) domestically and internationally, mentoring junior CRAs, and collaborating with cross-functional teams to drive site readiness and study execution in a

Qualifications

• Bachelor’s degree in a relevant field.
• Strong English communication skills.
• Experience in clinical trials monitoring.

Responsibilities

• Build and sustain relationships with investigative sites across trial phases.
• Perform site management and monitoring in line with ICH-GCP and local regs.
• Develop deep understanding of study protocols.
• Coordinate cross-functional tasks to achieve Site Ready status.
• Conduct remote and on-site monitoring to ensure data integrity and subject safety.
• Manage regulatory documentation for start-up, maintenance and close-out.
• Mentor junior CRAs and participate in co-monitoring visits.
• Travel domestically and internationally ~65–75% of time.

Skills

English fluency

ICH/GCP knowledge

Site management

Monitoring

Regulatory compliance

Mentoring

Data integrity

Audit support

Cross-functional

Communication

Education

Bachelor's degree (or higher) in bio/pharma/CRO

Tools

CTMS

eTMF

MS Office

Job description

Location London, London, United Kingdom Job Type Full time

Job Description

Clinical Research Associate

Location: UK Nationwide

Travel: Approximately 65–75% (about 2–3 days per week, domestic and international)

About our 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.

Role overview

We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements.

You will take ownership of allocated sites, actively expand our clinical research territory by identifying and developing new sites and contribute as a subject matter expert on monitoring processes and systems across internal workstreams.

Key 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; elevate 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.
• Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week).
• Valid driver’s license preferred; required in certain countries.

Qualifications, skills, and experience

Core competencies

• 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.

Education and experience

• Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO.

What we offer

• 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.

Required Skills

Adverse Event Reporting System, Clinical Development, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP)

Preferred Skills

Clinical Trials

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Remote

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/7/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R423668