Clinical Research Quality Assurance Specialist III

Purpose

The Clinical Research Quality Assurance Specialist III is responsible for the oversight of clinical research study protocols of the highest complexity with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Specialist III will coordinate the day-to-day administrative activities of the program and will provide support to teams to facilitate the achievement of the program’s goals.

Primary Functions

• Oversee quality assurance and oversight of research protocols of the highest complexity.
• Review requests, obtain Internal Review Board (IRB) approval, submit amendments and annual reports to the IRB for clinical trial drugs for expanded access.
• Lead the collaborative development and dissemination of clinical research education as needed in accordance, with federal regulations, institutional policies, and specific protocol requirements.
• Collaborate in the development and updates to guidelines, policies, and procedures.
• Apply extensive knowledge of clinical research to provide recommendations and direction to clinical research teams, faculty, and learners to ensure compliance.
• Lead meetings to disseminate quality assurance findings.
• Lead teams to resolution of clinical research non-compliance through root cause analysis, corrective, and preventative action plans.
• Provide support / guidance to investigators on Institutional regulatory requirements
• Oversee the Division's annual IRB submissions to prevent expirations and support investigators with study closures or transfers.
• Oversee the development and implementation of databases. Implement quality control processes to ensure integrity of the data and research standards are met.
• Provide regulatory support, participate in interactions, correspondence and reporting to the FDA and other external agencies.
• Participate in relevant committees to advance the program.
• Other duties as assigned.

Preferred Schedule :

Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.

Position Requirements :

Knowledge – Skills – Abilities

Extensive knowledge of FDA regulations, ICH GCP, institutional and departmental policies, and procedures

Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Specifications

Appropriate experience may be substituted on equivalent basis

Minimum Required Education : Bachelor’s degree in related field

Minimum Required Experience : 6 Years

Preferred Education : Master’s degree in related field

Preferred Experience : 3 years of experience in a medical research or educational environment preferred. Prior work with clinical research or patient care preferred.

Field : Related scientific field

Certification : Clinical Research Certification from ACRP, SOCRA, or an equivalent organization

MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination

The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity / expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.