Clinical Research Quality Assurance Specialist III

Every great life-changing discovery begins the same way—with new knowledge. It can change everything, from a single life to the future of entire communities. That’s why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin (MCW). In the role ofa Clinical Research Quality Assurance Specialist III you will beworking in our Center for Cancer Discovery.

Purpose

The Clinical Research Quality Assurance 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 with a focus on regulatory. 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.
• Lead the development and dissemination of clinical research education as needed in accordance, with federal regulations, institutional policies, and specific protocol requirements.
• Lead the development of departmental policies, procedures, and guidelines.
• Apply extensive knowledge of clinical research to provide recommendations and direction to clinical research teams 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.

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.

#LI-AV1

Preferred Schedule :

Fulltime 8 : 00-4 : 30

Position Requirements :

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education : Bachelors

Minimum Required Experience : 6 Years

Field : Related scientific field

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

Why MCW?