Clinical Research Associate (CRA) – Clinical Operations
Job Type: Full-Time
Work Schedule: Monday–Friday (Standard Business Hours)
Work Environment: Office / Field-Based / Travel Required
Industry: Clinical Research / CRO / Life Sciences
Job Overview
A leading global Contract Research Organization (CRO) is seeking a Clinical Research Associate (CRA) to support end-to-end clinical trial monitoring and site management activities within its global Clinical Operations division.
This role is part of a high-performing clinical research team delivering comprehensive clinical trial services across commercial and government-sponsored studies. The CRA will ensure that clinical trials are conducted in compliance with approved protocols, ICH-GCP guidelines, regulatory requirements, and sponsor SOPs while safeguarding subject safety, data integrity, and audit readiness.
The position may involve remote and on-site monitoring visits and requires independent travel.
Key Responsibilities
Clinical Trial Monitoring & Site Management
Perform and coordinate all aspects of site monitoring activities using a risk-based monitoring (RBM) approach
Conduct on-site and remote monitoring visits (qualification, initiation, routine, and close-out visits)
Ensure protocol compliance, regulatory adherence, and data reliability
Apply root cause analysis (RCA) and problem-solving techniques to address site performance issues
Ensure audit readiness and inspection preparedness
Data Verification & Quality Assurance
Perform Source Data Review (SDR) and Source Data Verification (SDV)
Review Case Report Forms (CRFs) for accuracy and completeness
Ensure clinical trial data is recorded accurately and in a timely manner
Assess investigational product accountability through inventory and records review
Regulatory & Compliance Oversight
Ensure essential documents are complete and maintained per ICH-GCP and applicable regulations
Escalate deficiencies to clinical management and ensure timely resolution
Respond to audits, inspections, and regulatory inquiries
Maintain updated documentation in Clinical Trial Management Systems (CTMS)
Site & Stakeholder Management
Develop and maintain collaborative relationships with investigative sites
Support investigator identification and site feasibility processes
Participate in investigator meetings and site training
Maintain ongoing communication between sponsor, project team, and investigative sites
Support investigator payment processes
Reporting & Administrative Responsibilities
Submit monitoring visit reports and follow-up letters within required timelines
Provide trial status updates to Clinical Team Manager (CTM)
Complete administrative requirements including expense reports and timesheets
Contribute to process improvement initiatives and project deliverables
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field
OR
Registered Nursing certification or equivalent academic qualification
Experience Required
Minimum 2+ years of experience as an on-site Clinical Research Associate (CRA) or Clinical Monitor
Experience in risk-based monitoring (RBM) methodologies
Experience conducting site initiation, monitoring, and close-out visits
Valid driver’s license (where applicable)
Willingness to travel independently (travel percentage may vary by region)
Equivalent combinations of education, training, and directly related clinical monitoring experience may be considered.
Technical Knowledge & Skills
Strong knowledge of ICH-GCP guidelines and global regulatory requirements
Understanding of clinical trial phases and therapeutic area fundamentals
Proficiency in Source Data Verification (SDV) and Source Data Review (SDR)
Experience with Clinical Trial Management Systems (CTMS)
Investigational product accountability management
Risk-Based Monitoring (RBM) expertise
Root Cause Analysis (RCA) and corrective action planning
Microsoft Office proficiency and ability to learn sponsor systems
Core Competencies
Strong critical thinking and analytical skills
Excellent written and verbal communication skills in English
Effective stakeholder and site relationship management
High attention to detail and data accuracy
Strong organizational and time management skills
Ability to work independently and within cross-functional teams
Adaptability in dynamic clinical trial environments
Customer-focused mindset
Work Environment & Travel
Office-based and field-based responsibilities
Exposure to healthcare or laboratory environments
Independent travel required (domestic and/or international as applicable)
Ability to manage multiple projects under timelines and performance metrics
Why Apply
Work on global, multi-country clinical trials across therapeutic areas
Be part of a leading CRO delivering innovative clinical research solutions
Gain exposure to decentralized, digital, and hybrid clinical trial models
Contribute to improving global patient outcomes
Apply Now
Advance your career in Clinical Monitoring, Clinical Operations, and Global Clinical Research by joining a world-class clinical research team committed to accelerating drug development and improving public health outcomes worldwide.
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