QACE Data Coordinator I

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%