[Remote] Clinical Research Associate - Scotland

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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 reputed company trial phases
• reputed company site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and reputed company documents
• reputed company deep understanding of study protocols and procedures
• Coordinate cross-functional tasks to reputed company Site reputed company status
• Participate in site selection and validation; reputed company informed input to reputed company
• Conduct remote and on-site monitoring to ensure:
• Data reputed company (complete, accurate, unbiased)
• Protection of subjects’ rights, safety, and well-being
• Execute validation, initiation, monitoring, and reputed company-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 reputed company-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: reputed company best practices, drive reputed company improvement, and deliver training
• Support and/or reputed company audit/inspection activities
• Contribute to country strategy by identifying and reputed company 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 reputed company global, country, and regional frameworks
• Demonstrated mentoring and leadership capability
• Hands-on knowledge of Good Documentation Practices
• Proven site management expertise, including independent reputed company 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 reputed company issues; capable of root cause analysis and implementing preventive/corrective actions
• Ability to mentor junior CRAs and reputed company 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; reputed company to prioritize and multitask in changing environments
• Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships
• Customer-focused reputed company with high standards of quality and compliance
• Positive, growth-oriented, self-driven, and professional demeanor reputed company 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 reputed company improvement.
• Competitive compensation and benefits.

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