Clinical Data Coordinator: ALCOA+, FDA & GCP Compliance

Dm Clinical Research Group; Karachi Division; On-site; PKR 1,674,000 - 2,120,000; Full time

Job summary

Dm Clinical Research Group in Karachi is seeking a qualified Clinical Research Associate to gather and review study data, ensure data integrity, and coordinate with regulatory and site teams. The role requires strong attention to detail and knowledge of ICH-GCP and FDA standards.

The candidate will monitor data quality, coordinate with QA, manage query resolution, and support site visits and sponsor audits while maintaining strict timelines and documentation practices.

Qualifications

• Meticulous attention to details and deadlines.
• Experience with relevant regulations and guidelines (ICH-GCP, FDA, ALCOA+).
• Experience with clinical data management systems and auditing processes.
• Quality assurance and quality control in a clinical setting.

Responsibilities

• Collect clinical research data from various sources to ensure study quality.
• Collaborate with regulatory, clinical data, and research site teams.
• Review study data and capture action items from site visits, sponsor audits, and remote monitoring.
• Escalate issues lacking resolution.
• Ensure adherence to ALCOA+, GDP, GCP and FDA regulations.

Skills

Attention to detail

Problem solving

Communication skills

Organization

Education

Foreign Medical Graduate

PharmD

Clinical Research Professional

Advanced Degree in Health Science

Tools

Clinical data management systems

Auditing processes

Job description

Dm Clinical Research Group in Karachi is seeking a qualified Clinical Research Associate to gather and review study data, ensure data integrity, and coordinate with regulatory and site teams. The role requires strong attention to detail and knowledge of ICH-GCP and FDA standards.

The candidate will monitor data quality, coordinate with QA, manage query resolution, and support site visits and sponsor audits while maintaining strict timelines and documentation practices.