Clinical Research Quality Assurance Specialist I

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 Clinical Research Quality Assurance Specialist I, you will be working in our Cancer Center.

Purpose

Under close supervision, the Clinical Research Quality Assurance Specialist I is responsible for the oversight of clinical research study protocols with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Specialist I 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 quality assurance and oversight of the research protocols.
• Use emerging knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Contribute to the development of departmental policies, procedures, and guidelines.
• Apply emerging knowledge of clinical research to assist with recommendations and direction to clinical research teams to ensure compliance.
• Conduct meetings to disseminate quality assurance findings.
• Assist in resolving clinical research non-compliance through root cause analysis, corrective, and preventative action plans.

Knowledge – Skills – Abilities

Basic knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures. Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Position Requirements

Specifications

Appropriate experience may be substituted for education on an equivalent basis.

Minimum Required Education: Bachelors degree

Minimum Required Experience: 2 Years

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.

MCW is an Equal Opportunity Employer and Commitment to Non-Discrimination. The Medical College of Wisconsin (MCW) is 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.