Clinical Research, Internal Quality Assurance Associate
About The Position
The Internal Quality Assurance Associate supports the day-to-day quality assurance operations of the Clinical Research Department by assisting with the implementation and continuous improvement of the Quality Management System (QMS). This role collaborates with Clinical Research, Quality, and Training teams to support quality initiatives, develop and maintain Standard Operating Procedures (SOPs) and controlled documents, manage document control and Learning Management System (LMS) processes, and assist with internal and external audits and regulatory inspections. The associate ensures compliance with CSTL policies, Good Clinical Practice (GCP), and applicable regulatory requirements while promoting quality, supporting staff training, and maintaining the integrity of clinical research activities and human subject protections.
Requirements
- Associate degree in related field.
- Minimum of 2 years of proven experience in clinical quality assurance, training, compliance, regulatory, or a related role.
- A minimum of 2 years in clinical research.
- Fundamental understanding of medical/therapeutic area knowledge and medical terminology.
- Highly skilled in Microsoft Office, proficiency in Microsoft Word and Excel, and the ability to learn appropriate software.
- All candidates must be legally authorized to work in the United States.
Nice To Haves
- Bachelor's degree in related field or demonstrated experience as evidence of competency.
- Previous experience with complex, global trials.
- Competent in study development processes, current industry standards, such as, but not limited to: ICH GCP, ISO 14155, IDE requirements, HIPAA, GDPR guidelines, Quality Management Systems, and 21 CFR Part 11 guidelines.
Responsibilities
- Assisting with the implementation and continuous improvement of the Quality Management System (QMS).
- Collaborating with Clinical Research, Quality, and Training teams to support quality initiatives.
- Developing and maintaining Standard Operating Procedures (SOPs) and controlled documents.
- Managing document control and Learning Management System (LMS) processes.
- Assisting with internal and external audits and regulatory inspections.
- Ensuring compliance with CSTL policies, Good Clinical Practice (GCP), and applicable regulatory requirements.
- Promoting quality, supporting staff training, and maintaining the integrity of clinical research activities and human subject protections.
Benefits
- Excellent Annual Salary + 20% Bonus Potential
- 20 Accrued PTO Days Annually
- 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options
- Company HSA Contribution
- Company Stock Grant Upon Hire
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
