The QACE Data Coordinator 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 data obtained from various sources to identify issues and anomalies that could impact a study’s overall quality.
• Collaborate with teams, such as, QACE team, regulatory team, data team, clinical data, and other research staff to ensure all respective data is available.
• Present findings to stakeholders and communicate corrective action plans.
• Review study data and accurately capture all action items they contain, including but not limited to regular scheduled visits, sponsor audits, remote monitoring visits.
• Investigate to see if Action Items by respective stakeholders, both internal and external, have been addressed by the site.
• Apply clinical knowledge of checking to see if queries are addressed properly and communicate/escalate any issues that don’t have a satisfactory resolve.
• Ensure the adherence to ALCOA+, GDP, GCP Standards with all relevant clinical trial documentation.
• Conduct review of source creation for clinical studies.
• 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.
• Assist in the training of new team members.
• 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+) and experience working with clinical data management systems.
• Experienced in spreadsheet software, Microsoft Excel, Google Sheets.
• Experience in quality assurance and quality control in a clinical setting
• Experienced in auditing processes

Knowledge and Skills:

• Meticulous attention to details and deadlines.
• Knowledge of basic use 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.