Clinical Research Quality Assurance Specialist II - Cancer Center

Summary

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 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 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 year’s

Physical Requirements

Work requires occasionally lifting moderate weight materials, standing, or walking continuously.

Work Environment

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.

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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

• 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

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. For more information, please visit our institutional website.

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.