QACE Data Coordinator
Remote
Contracted
QA & Clinical Excellence
Entry Level
QACE Data Coordinator (Remote)
The Quality Assurance & Clinical Excellence 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
KNOWLEDGE & EXPERIENCE
Education:
The Quality Assurance & Clinical Excellence 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
- 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.
- 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.
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