QACE Data Coordinator I (4260)

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 studys 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 dont 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%