Medical College of Wisconsin
Clinical Research QA Manager - Education
Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53244
Every day, in ways both big and small, the Medical College of Wisconsin (MCW) is impacting lives for the better. MCW … changemaking for a healthier Wisconsin.In the role of a Clinical Research Quality Assurance Manager you will beworking in our Center for Cancer Discovery.
Purpose The Clinical Research Quality Assurance Manager is responsible for the education and oversight of clinical research study staff who work on protocols of all complexity levels with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Manager will oversee 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 Functions
Manage training, continuing education, quality assurance, compliance, and operational oversight of the research protocols.
Manage the development and implementation of clinical research education, systems support, study operational planning, and organizational tools to ensure compliance with federal regulations, institutional policies, and specific protocol requirements.
Oversee and manage the development departmental policies, procedures, and guidelines.
Apply extensive knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure compliance.
Manage and oversee meetings to develop educational plans related to quality assurance findings and updated workflows.
Direct teams to resolution of clinical research non-compliance through root cause analysis, corrective, and preventative action plans.
Knowledge – Skills – Abilities Extensive knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures.
Data utilization, complex problem solving, critical thinking, resource management, and writing skills.
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Purpose The Clinical Research Quality Assurance Manager is responsible for the education and oversight of clinical research study staff who work on protocols of all complexity levels with an emphasis on quality, training, monitoring, and the development of tools for study team use. The Clinical Research Quality Assurance Manager will oversee 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 Functions
Manage training, continuing education, quality assurance, compliance, and operational oversight of the research protocols.
Manage the development and implementation of clinical research education, systems support, study operational planning, and organizational tools to ensure compliance with federal regulations, institutional policies, and specific protocol requirements.
Oversee and manage the development departmental policies, procedures, and guidelines.
Apply extensive knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure compliance.
Manage and oversee meetings to develop educational plans related to quality assurance findings and updated workflows.
Direct teams to resolution of clinical research non-compliance through root cause analysis, corrective, and preventative action plans.
Knowledge – Skills – Abilities Extensive knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures.
Data utilization, complex problem solving, critical thinking, resource management, and writing skills.
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