Minerva Research Solutions
Compliance Coordinator (Clinical Trials)
🇵🇰Karachi, Sindh, Pakistan6 days ago
MidFull TimeEN
Minerva Research Solutions is a leading Clinical Trial Management and Support organization dedicated to elevating global healthcare outcomes through innovation, operational excellence, and uncompromising quality. We partner with biotech, pharmaceutical, and healthcare institutions to deliver integrated services across the clinical trial value chain — from feasibility to closeout.
Our portfolio spans Data Operations, Patient Recruitment, and Regulatory Services, enabling clients to accelerate the development of breakthrough therapies with accuracy, agility, and regulatory confidence. Governed by FDA and ICH-GCP standards, we are committed to delivering data integrity, participant safety, and reliable insights at every touchpoint.
The Compliance Coordinator is responsible for supporting and ensuring adherence to GCP guidelines across clinical research activities. This role involves oversight of quality processes, auditing, communication standards, and performance monitoring to maintain compliance across study operations.
Ensure compliance with GCP guidelines, study protocols, and departmental SOPs.
Support regulatory compliance oversight across all ongoing and new studies.
Monitor and track compliance metrics and escalate non-compliance issues as needed.
Track and monitor leads after generation in accordance with SOPs and approved processes.
Ensure proper documentation, timely follow-up, and compliance in patient recruitment workflows.
Identify and flag any deviations or risks in patient recruitment processes.
Conduct regular call reviews to assess communication quality and adherence to approved SOPs and guidelines.
Provide feedback and recommendations to improve patient interaction and communication standards.
Perform subject data spot checks (QC) to ensure accuracy, completeness, and integrity.
Document findings and support Corrective and Preventive Action (CAPA) processes.
Support oversight of PI activities to ensure compliance with protocols and regulatory requirements.
Monitor PI engagement, documentation, and study conduct standards.
Ensure proper use and compliance of electronic source (eSource) systems.
Verify data integrity, audit trails, and adherence to documentation standards.
Develop and maintain Clinical Research Coordinator (CRC) performance reports.
Analyze performance trends and provide actionable insights for improvement.
Support compliance readiness during study start-up activities.
Ensure all regulatory documents, approvals, and processes are in place prior to study initiation.
Bachelor’s degree in Biosciences, Pharmacy, Life Sciences, or a related field.
Minimum 1 year of experience in clinical research, compliance, or quality assurance.
Strong understanding of ICH-GCP, regulatory guidelines, and clinical trial processes.
Experience with audits, QC processes, and compliance monitoring is preferred.
Strong attention to detail and analytical skills
Excellent communication and feedback delivery skills
Ability to manage multiple tasks and prioritize effectively
Proficiency in clinical systems and reporting tools
Problem-solving and critical thinking abilities
Strong documentation and reporting capabilities
Competitive compensation with performance-based rewards
Comprehensive medical insurance
EOBI retirement benefits
Structured Learning & Development pathways, including certifications and career mobility
Paid annual, medical, and casual leave
Mental well-being and employee support programs
Inclusive, collaborative, and growth-driven work culture
Internal recognition & employee engagement initiatives
Modern digital tools and a technology-forward workplace
Transportation allowance for staff
Family-supportive policies, including parental leave
Opportunities to contribute to community and social impact programs
