QACE Data Coordinator I (4260)

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

Job DetailsJob Location: Corporate - Karachi (KHI) - Karachi, Sindh 75600

DUTIES & RESPONSIBILITIES

• Collect clinical research data obtained from various sources to identify issues and inconsistencies that could impact a study’s overall quality.
• Collaborate with teams, such as the regulatory, clinical data, and research site teams, to ensure all respective data is available.
• Review study data and accurately capture all action items, including those arising from scheduled site visits, sponsor audits, and remote monitoring.
• Communicate/escalate any issues that don’t have a satisfactory resolution
• Ensure the adherence to ALCOA+, GDP, GCP Standards, and FDA regulations with all relevant clinical trial documentation.
• Conduct review of source creation for clinical studies against applicable documents, such as, the study protocol, lab manual, and pharmacy manual.
• Add issues found on the query management system to keep a central repository of all items.
• Identify trends and patterns which may have a potential impact on study outcomes and communicate to stakeholders in a clear and concise manner.
• Submit required administrative paperwork per company timelines.
• Any other matters, as assigned by management.

KNOWLEDGE & EXPERIENCE

Education:

• Foreign Medical Graduate/PharmD/Clinical Research Professional/Advanced Degree in Health Science

Experience:

• 1+ years experience in a functional clinic setting, demonstrating ability to handle clinical problem-solving skills.
• Experience with relevant regulations and guidelines (e.g., ICH-GCP, FDA regulations, ALCOA+).
• Experience with working with clinical data management systems and auditing processes.
• Experience in quality assurance and quality control in a clinical setting.

Credentials:

N/A

Knowledge and Skills:

• Meticulous attention to details and deadlines.
• Knowledge of scientific methods, procedures, and techniques.
• Exceptional problem solving skills, and root cause analysis of issues.
• Ability to work independently and as part of a team.
• Strong communication, organizational, and interpersonal skills.
• Proficiency in spreadsheet software (e.g., Microsoft Excel, Google Sheets).

KPI & Success Metrics

• Average minimum number of chart reviews per day= 5 per day
• Valid findings review percentage= 85%
• Paycom training completion by deadline= 95%
• Successful Priority task completion by deadline= 95%

Qualifications