QACE Data Coordinator I (4260)

Job Details: Job Location: Corporate - Karachi (KHI) - Karachi, Sindh, Salary Range: Undisclosed, The QACE Data Coordinator I role is a critical position that requires the candidate to identify and investigate clinical related issues and trends which may impact study outcomes and/or study integrity.

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: