Clinical Research Associate

About this role

Responsibilities

• Site Management & Monitoring:
• Develop and maintain strong, collaborative relationships with investigators and site staff, ensuring continuity throughout all trial phases.
• Perform all aspects of clinical site management and monitoring in accordance with ICH-GCP, Sponsor SOPs, local laws and regulations, the study protocol, Site Monitoring Plan, and related documents.
• Gain and maintain in-depth knowledge of assigned study protocols and study-specific procedures.
• Conduct on-site and remote monitoring and oversight activities, using a variety of tools and systems to ensure: Data generated at the site are complete, accurate and unbiased. The rights, safety, and well-being of trial participants are protected.
• Plan, conduct, and document site visits including, but not limited to, site validation/feasibility, initiation, routine monitoring, and close-out visits.
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports.
• Study Start-Up, Maintenance & Close-Out:
• Collect, review, and track required regulatory and site documentation to support study start-up, ongoing conduct, and close-out.
• Coordinate and manage tasks with cross-functional colleagues to ensure sites achieve Site Ready status within agreed timelines.
• Participate in and provide input for site selection and validation activities.
• Manage and maintain accurate, timely information and documentation in CTMS, eTMF and other relevant systems.
• Quality, Compliance & Performance Management:
• Ensure sites operate in full compliance with ICH-GCP, local regulations, and internal quality standards.
• Identify, assess, and resolve site performance, quality, or compliance issues; escalate as appropriate in line with the CRA Escalation Pathway and in collaboration with the CRA Manager, Country Research Manager (CRM), Therapeutic Area (TA) Head, and Clinical Research Director (CRD).
• Support and/or lead preparation for, and participation in, audits and inspections; conduct co-monitoring visits as required.
• Cross-Functional Collaboration & Territory Development:
• Work closely with key internal stakeholders including GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, and HQ functional areas.
• Collaborate externally with vendors, IRB/IECs and regulatory authorities as needed in support of your sites.
• Contribute to the country/site strategy as defined by the CRD and/or CRA Manager, including identifying and developing new potential investigator sites and strengthening clinical research capabilities across the territory.
• Knowledge Sharing & SME Responsibilities:
• Act as a process SME and actively contribute to CRA team knowledge and capability development.
• Serve as buddy/mentor to less experienced CRAs, sharing best practices and supporting their onboarding and development.
• Participate in internal meetings and working groups focusing on monitoring processes, systems, and continuous improvement initiatives.
• Core Competencies & Technical Skills:
• Fluency in local language(s) and English (verbal and written), with excellent communication and presentation skills, including the ability to convey technical information clearly.
• Solid understanding of clinical research principles, clinical trial phases, and current GCP/ICH and local clinical research regulations and guidelines.
• Good understanding of global and local clinical research guidelines and the ability to work within these requirements.
• Practical knowledge of Good Documentation Practices.
• Proven skills in site management, including oversight of site performance and patient recruitment/retention strategies.
• Demonstrated high level of monitoring skills with sound, independent professional judgment.
• Strong IT skills, including proficiency with MS Office and various clinical IT applications (e.g., CTMS, eTMF, EDC) on computer, tablet, and mobile devices; ability to quickly learn and adapt to new tools.
• Ability to interpret, analyze and act on data/metrics related to site performance, quality, and timelines.
• Capable of managing complex issues in a solution-oriented manner, including performing root cause analyses and implementing corrective and preventive actions (CAPA).
• Behavioral Competencies:
• Effective time management, organizational, interpersonal, conflict management and problem-solving skills.
• Ability to work highly independently across multiple protocols, sites and therapeutic areas, with minimal supervision.
• Strong sense of accountability and urgency; able to set priorities and manage multiple tasks in a dynamic environment.
• Demonstrated ability to work effectively in a matrixed, multicultural environment and maintain culturally sensitive working relationships.
• Strong customer focus and collaborative mindset.
• Consistently high quality and compliance orientation with attention to detail.
• Positive, growth-oriented mindset; self-driven, proactive, and resourceful.
• Professional demeanor and communication style aligned with organizational standards and values.
• Experience & Education:
• Bachelor’s degree (or higher) in a scientific or healthcare-related discipline.
• Minimum of 6 months experience in monitoring activities.