Clinical Research Quality Assurance Specialist II – Activation, Cancer Center

MCW

Clinical research QA specialist overseeing complex cancer-center protocols at MCW. Developing training, policies, and corrective actions to ensure regulatory compliance.

Posted 8/18/2026full-timeWauwatosa • Wisconsin • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and compliance within clinical research, with a strong foundation in FDA regulations and ICH GCP. Capable of developing educational materials and departmental policies while effectively managing resources and problem-solving.

Highest-signal resume keywords

Quality Assurance OversightFDA Regulations KnowledgeICH GCP FamiliarityClinical Research Education DevelopmentRoot Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceClinical Research ProtocolsData UtilizationComplex Problem SolvingCritical ThinkingResource ManagementWriting SkillsPolicy DevelopmentCorrective Action PlansCompliance Recommendations

Soft Skills

Communication SkillsTeam CollaborationMeeting Facilitation

Industry Keywords

Federal RegulationsInstitutional PoliciesDepartmental ProceduresClinical Research ComplianceAdministrative Coordination

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Perform quality assurance and oversight of higher-complexity research protocols
Develop and disseminate clinical research education in accordance with federal regulations, institutional policies, and protocol requirements
Develop departmental policies, procedures, and guidelines
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 and corrective and preventative action plans
Coordinate day-to-day administrative activities of the program
Support teams in achieving the program’s goals

Requirements

What you’ll need

Appropriate experience may be substituted for education on an equivalent basis
Minimum Required Education: Bachelor’s degree
Minimum Required Experience: 4 year’s
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
Ability to detect and translate speech or other communication
May occasionally require the ability to distinguish colors and perceive relative distances between objects
Ability to occasionally lift moderate weight materials
Ability to stand or walk continuously
Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids

Benefits

Comp & perks

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.