Senior Clinical Research Associate Scotland

Job Description

Senior Clinical Research Associate

Location: Scotland

Travel: Approximately 6575% (about 23 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 Senior Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within Scotland. 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; 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.

Travel requirements

• Ability to travel domestically and internationally approximately 6575% of working time (about 23 days per week).
• Valid drivers 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.

Behavioral competencies

• 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

• Bachelors 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.

How to apply Please submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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.

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