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.

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

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.

Research Quality Analyst – Clinical Trials

Key skills