Clinical Research Quality Assurance Specialist II - Cancer Center

The Medical College of Wisconsin•Milwaukee, WI

6d•Onsite

About The Position

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.

Requirements

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.
Bachelor’s degree
4 year’s experience

Nice To Haves

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

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.

Benefits

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.