Clinical Research Quality Assurance

JOB REQUIREMENTS: 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. #LI-AV1 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... For full info follow application link. EEO/AA Minorities/Females/Vets/Disability The Medical College of Wisconsin is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/BF34D728A15B48F2 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.