Hybrid Research Quality Analyst - CCC | Clinical Trials Office na The Ohio State University

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Job Title:

Research Quality Analyst - CCC | Clinical Trials Office

Department:

CCC | Clinical Trials Office

Position 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:

Regular

Scheduled Hours:

40

Shift:

First Shift

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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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