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Research Quality Analyst – Clinical Trials
The Ohio State University, Main CampusResearch Quality Analyst working with clinical trials to ensure compliance with quality standards. Performing quality checks, managing audits, and developing improvement processes in a hybrid work setting.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Performs detailed internal quality checks on essential regulatory files and patients enrolled on a clinical trial applying professional research experience to assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOPs), Good Clinical Practices (GCP) and all applicable regulations.
- Recommends necessary steps to resolve any identified compliance issues identified on internal quality checks.
- Manages corrective and preventative action plans in response to internal/external audits, FDA Inspection or sponsor monitoring visits.
- Serves as a resource for less experienced colleagues.
- Develops new quality improvement processes to ensure on-going compliance to quality standards for the conduct of all clinical trials with the CTO.
- Develops and presents reports to operations managers and CTO directors.
Requirements
What you’ll need- Bachelor's degree in scientific discipline, or an equivalent combination of training and experience
- Minimum 1 year experience in clinical research and/or healthcare-related field
- Clinical research certification from an accredited certifying agency desired
- Computer skills required with experience using Microsoft Software applications desired
- Previous quality assurance experience with clinical trials preferred
Benefits
Comp & perks- Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
- Paid time off, including sick and vacation time and 11 holidays.
- State retirement plan or an alternative retirement plan, both with generous employer contributions.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality checksdata integrityresearch compliancecorrective action planspreventative action plansquality improvement processesclinical researchquality assurance
Soft Skills
communicationmentorshipproblem-solving
Certifications
clinical research certification