New

Clinical Research Quality Assurance Specialist II

Medical College of Wisconsin

parental leave, paid holidays, tuition reimbursement, 403(b)

United States, Wisconsin, Milwaukee

Apr 07, 2025

Position Description:

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care. Tomorrow's discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities. In the role of a Clinical Research Quality Assurance Specialist II you will be working in our Cancer Center.

Purpose

Under general supervision the Clinical Research Quality Assurance Specialist II is responsible for the oversight of clinical research study 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 assist in logistical and operational feasibility assessments, coordinate the implementation of research projects and 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 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 disseminate quality assurance findings.
Work with teams to resolve clinical research non-compliance through root cause analysis, corrective, and preventative action plans
Assist with the development and implementation of processes to ensure efficiencies between the CTO and collaborating departments. Utilize CTO quality improvement tools & process control to facilitate improvement of systems & processes.

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, communication and writing skills.

#LI-AV1

Preferred Schedule:

Fulltime 8:00-4:30

Position Requirements:

Specifications

Appropriate experience may be substituted for education on equivalent basis

Minimum Required Education: Bachelors degree

Minimum Required Experience: 4 Years

Preferred Experience: Clinical Research Coordination

Field: Related scientific field

Certification: CITI training within 90 days of hire

Why MCW?

Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Pet Insurance
On campus Fitness Facility, offering onsite classes.
Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

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

For a brief overview of our benefits see: https://www.mcw.edu/departments/human-resources/benefits

Eastern Wisconsin is a vibrant, diverse metropolitan area. MCW is intent on attracting, developing, and retaining a diverse workforce and faculty body that reflects the community we serve. We value diversity of backgrounds, experience, thought, and perspectives to advance excellence in science and medicine. MCW is a welcoming campus community with a strong culture of collaboration, partnership, and engagement with our surrounding community. For more information, please visit our institutional website at https://www.mcw.edu/departments/office-of-diversity-and-inclusion.

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.