Clinical Research Quality Assurance Specialist II - Cancer Center

Primary Responsibilities

• 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.

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.

Qualifications

• Appropriate experience may be substituted for education on an equivalent basis.
• Minimum Required Education: Bachelor’s degree.
• Minimum Required Experience: 4 years.

Physical Requirements

• Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids.
• Work is performed in an environmentally controlled environment.
• Sensory Acuity: Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental.
• Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• Paid Parental Leave
• Employee & Family Assistance Program (EFAP)
• 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 brief overview of our benefits see:

• Benefits Overview

For a full list of positions see:

• MCW Careers

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.