Job Description Job Title: Clinical Research Associate (CRA) Location: South West Region UK Make an impact on global health by driving high-quality clinical research. In this role, you’ll be the primary site contact and operational lead across all phases of clinical trials—ensuring excellence in performance, compliance, and patient safety. Under the guidance of the CRA Manager, you’ll own your sites end-to-end, build strong relationships, and help expand our clinical footprint while upholding ICH/GCP and local regulatory standards, our organization’s policies and procedures, quality standards, and adverse event reporting requirements. What you’ll do Be the primary site contact and site manager throughout the study lifecycle, taking overall accountability for assigned sites Build, nurture, and maintain strong site relationships to ensure stable performance from start-up through close-out Perform remote and on-site monitoring in accordance with ICH-GCP, local regulations, protocol, monitoring plans, and our organization’s SOPs Ensure high-quality data: complete, accurate, unbiased—and always with participant rights, safety, and well-being protected Conduct all site visit types (validation, initiation, monitoring, close-out), with timely, clear, and comprehensive reporting Drive site readiness: coordinate cross-functional activities and contribute to site selection and validation Oversee regulatory documentation across start-up, maintenance, and close-out; ensure accuracy and timeliness Identify, assess, and resolve site performance, quality, and compliance issues; escalate per the CRA Escalation Pathway when needed in collaboration with the CRA Manager, CRM, TA Head, and CRD Partner across functions (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and with external stakeholders (vendors, IRBs/IECs, Regulatory Authorities) Maintain accurate, on-time documentation in CTMS, eTMF, and related systems Share expertise as a process SME; mentor/buddy peers and contribute to team best practices Support or lead audit/inspection activities; conduct co-monitoring as appropriate Expand our research network: identify and develop new potential sites per country strategy, strengthening local research capabilities What you’ll bring Demonstrated experience in clinical monitoring/site management within biopharma, CRO, or academic research Strong working knowledge of ICH-GCP, local regulations, and clinical trial operations Proven ability to manage multiple sites, priorities, and stakeholders with a solutions-focused mindset Exceptional communication and relationship-building skills with investigators and site staff High attention to detail, documentation excellence, and proficiency with CTMS, eTMF, and digital monitoring tools Proactive problem-solving with sound judgment and timely escalation when needed Bachelor’s degree in life sciences or related field (advanced degree a plus) Why join us Meaningful impact: contribute directly to advancing clinical science and patient outcomes Growth and mentorship: act as a subject matter expert, mentor peers, and shape best practices Collaborative culture: work cross-functionally with supportive, high-performing teams Future-facing operations: leverage modern systems and monitoring approaches to deliver operational excellence Closing date for applications :23/01/2026 Required Skills: Accountability, Adaptability, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP) Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Remote Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.