Clinical Research QA Specialist II - Education

Position Description :

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 of a Clinical Research Quality Assurance Specialist II you will be working in our Center for Cancer Discovery.

Purpose

Under general supervision, the Clinical Research Quality Assurance Specialist II is responsible for the education and oversight of clinical research study staff who work on protocols of increasing complexity, with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Specialist II 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

• Perform training, continuing education, quality assurance and oversight of research protocols of higher complexity.
• Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Develop departmental policies, procedures, and guidelines.
• Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure compliance.
• Conduct meetings to develop educational plans related to quality assurance findings and updated workflows.
• Work with teams to resolve clinical research non-compliance through root cause analysis, corrective, and preventative action plans.

Knowledge - Skills - Abilities

Fundamental 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 degree

Minimum Required Experience : 4 Years

Field : Related scientific field

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

Why MCW?

For a full list of positions see : www.mcw.edu / careers

For a brief overview of our benefits see : departments / human-resources / benefits

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values : Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you.

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 an inclusive 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.