Clinical Research Associate

Job Description

The Clinical Research Associate (CRA) is accountable for the performance and compliance of assigned clinical study protocols and investigational sites within the country. Under the oversight of the CRA Manager, the CRA ensures that study conduct complies with ICH-GCP guidelines, local regulatory requirements, sponsor policies and procedures, quality standards, and adverse event reporting requirements.

The CRA serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The role also contributes to the development of clinical research capabilities by identifying and cultivating new investigator sites and participating as a subject matter expert (SME) in monitoring processes and systems.

Key Responsibilities

Site Management & Monitoring

• Develop and maintain strong relationships with investigational sites throughout all phases of the clinical trial lifecycle.
• Perform site management and monitoring activities in accordance with: ICH-GCP guidelines Sponsor SOPs Local laws and regulations Study protocol requirements Site Monitoring Plans and associated study documents
• Gain a comprehensive understanding of study protocols and related procedures.
• Coordinate and manage site readiness activities in collaboration with cross-functional stakeholders.
• Participate in site selection, qualification, and validation activities.
• Conduct remote and on-site monitoring activities to ensure: Data generated at sites are complete, accurate, and unbiased. Participant rights, safety, and well-being are protected.
• Conduct site visits including: Site qualification/validation visits Site initiation visits (SIV) Interim monitoring visits Close-out visits
• Prepare clear, comprehensive, and timely visit reports and documentation.

Regulatory & Compliance Management

• Collect, review, and maintain required regulatory documentation throughout study startup, maintenance, and close-out phases.
• Ensure compliance with applicable regulations, study protocols, and quality standards.
• Support audit and inspection readiness activities.
• Assist with or lead audit and inspection activities when required.
• Perform co-monitoring visits as appropriate.
• Maintain accurate and timely documentation within CTMS, eTMF, and other clinical systems.

Site Performance & Issue Management

• Communicate with investigators and site personnel regarding: Protocol implementation Patient recruitment and retention Protocol deviations Regulatory documentation Audits and inspections Overall site performance
• Identify, assess, and resolve site performance, quality, and compliance issues.
• Escalate risks and concerns through established escalation pathways when appropriate.
• Conduct root cause analyses and implement preventive and corrective actions (CAPAs).
• Monitor recruitment performance and support enrollment strategies.

Cross-Functional Collaboration

• Collaborate closely with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, ethics committees, and regulatory authorities.
• Support study delivery through effective stakeholder management and coordination.
• Contribute to team development by acting as: Subject Matter Expert (SME) Mentor or buddy Best-practice contributor

Site Development

• Support country clinical research strategies by identifying and evaluating new investigator sites.
• Partner with investigators and sites to enhance clinical research capabilities and performance.
• Expand and strengthen the local clinical research network.

Travel Requirements

• Domestic and international travel of approximately 65%-75% of working time.
• Expected travel frequency of approximately 2-3 days per week.

Core Competencies

Clinical & Technical Expertise

• Fluency in local language(s) and English, both written and verbal.
• Strong understanding of: Clinical research processes Clinical trial phases ICH-GCP guidelines Country-specific clinical research regulations
• Knowledge of global and regional clinical research requirements.
• Strong understanding of Good Documentation Practices (GDP).
• Proven site management and patient recruitment experience.
• Demonstrated monitoring expertise and sound professional judgment.
• Ability to analyze data and performance metrics and take appropriate action.

Systems & Technology

• Proficiency in Microsoft Office applications.
• Experience using clinical systems such as CTMS, eTMF, and mobile monitoring tools.
• Ability to quickly adopt new technologies and applications.

Problem Solving

• Ability to manage complex issues and work in a solution-oriented manner.
• Experience conducting root cause analyses and implementing corrective and preventive actions.
• Strong risk assessment and decision-making capabilities.

Behavioral Competencies

• Excellent time management and organizational skills.
• Strong interpersonal and communication skills.
• Effective conflict resolution and problem-solving abilities.
• Ability to work independently across multiple studies, sites, and therapeutic areas.
• Strong sense of accountability, urgency, and ownership.
• Ability to prioritize competing demands in a fast-paced environment.
• Demonstrated success working in multicultural and matrixed organizations.
• Strong customer-focused mindset.
• Commitment to quality, compliance, and continuous improvement.
• Positive attitude, growth mindset, and self-driven work ethic.
• Professional presence and communication style aligned with organizational standards.

Qualifications & Experience

• Bachelor's Degree or higher in a scientific or healthcare-related discipline; and
• Minimum 2 years of direct site management/monitoring experience within a pharmaceutical, biotechnology, or CRO environment.

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