Hybrid Research Quality Analyst - CCC | Clinical Trials Office at The Ohio State University
The Ohio State University · Columbus, United States Of America · Hybrid
- Professional
- Office in Columbus
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Job Title:
Research Quality Analyst - CCC | Clinical Trials OfficeDepartment:
CCC | Clinical Trials OfficePosition Summary
The Research Quality Analyst 2 works under the supervision of Quality Assurance Manager to ensure compliance to all processes contributing to the performance of a clinical trial within the Clinical Trials Office (CTO).
Responsibilities
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
Job Requirements
Bachelor's degree in scientific discipline, or an equivalent combination of training and experience
Minimum 1 years’ 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
Additional Information:
Location:
Optometry Clinic (1041)Position Type:
RegularScheduled Hours:
40Shift:
First ShiftFinal candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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The university is an equal opportunity employer, including veterans and disability.
As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
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