Senior Research Quality Analyst

Ohio State University; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Senior Research Quality Analyst to lead compliance efforts within clinical trials. This role involves conducting detailed quality checks, managing corrective actions, and collaborating with various teams to ensure adherence to regulations and guidelines. The ideal candidate will have a strong background in clinical research, excellent problem-solving skills, and the ability to mentor junior staff. Join this dynamic team and contribute to the success of critical clinical trials while ensuring the highest standards of quality and compliance.

Qualifications

• 3-5 years of experience in clinical research or related roles.
• Certification from an accredited agency is required.

Responsibilities

• Perform internal quality checks on regulatory files and patient data.
• Manage corrective action plans for audits and inspections.
• Develop quality improvement processes for compliance.

Skills

Clinical Research

Data Integrity

Regulatory Compliance

Quality Assurance

Microsoft Office

Education

Bachelor's Degree in Biological Sciences

Master's Degree

Job description

Senior Research Quality Analyst page is loaded

Senior Research Quality Analyst

Apply locations Columbus Campus time type Full time posted on Posted 12 Days Ago job requisition id R127723

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Job Title:

Senior Research Quality Analyst

Department:

CCC | Clinical Trials Office

Job Description

The Senior Research Quality Analyst serves as a lead resource to ensure compliance with all processes contributing to the performance of a clinical trial within the Clinical Trials Office (CTO).

Responsibilities

• Perform detailed internal quality checks on essential regulatory files and patients enrolled in clinical trials, assessing research participant safety, data integrity, and research compliance with SOPs, GCP, and applicable regulations.
• Recommend steps to resolve any compliance issues identified during internal quality checks.
• Manage corrective and preventative action plans in response to audits, FDA inspections, or sponsor visits.
• Serve as a resource and provide guidance to less experienced colleagues and the research team.
• Develop new quality improvement processes to maintain ongoing compliance.
• Develop and present reports to operations managers and CTO directors.
• Coordinate and assist with preparations for external audits by IRB, federal, or industry sponsors.
• Collaborate with CTO Training and Internal Monitoring Teams as needed.
• Participate in writing and implementing SOPs for the CTO.
• Maintain knowledge of relevant regulations and GCP guidelines.
• Serve as a subject matter expert for research quality analysts within the CTO.
• Review quality reports and support junior team members.
• Provide backup coverage for the Quality Assurance manager and team members.
• Work with CTO Managers and coordinators to ensure understanding of policies and procedures.

Minimum Education Required

Bachelor’s Degree in biological sciences, health sciences, social sciences, or a related field, or an equivalent combination of education and experience. A Master’s degree is preferred.

Three to five years of experience in clinical research or related administrative roles are required. Certification from an accredited agency is required. Computer skills with Microsoft Office are desired.

Additional Information:

Location:

Optometry Clinic (1041)

Position Type:

Regular

Scheduled Hours:

40

Shift:

Final candidates are subject to a background check. A drug screen or physical may be required during the post-offer process.

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