Clinical Research Quality Assurance Specialist II

Medical College of Wisconsin; Milwaukee (WI); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Quality Assurance Specialist II to join their Cancer Center team. In this role, you will oversee complex clinical research protocols, ensuring compliance with FDA regulations and ICH GCP standards. You will play a crucial role in developing educational resources and policies while collaborating with research teams to enhance operational efficiencies. This position offers an exciting opportunity to contribute to groundbreaking research and improve community health outcomes in a dynamic and supportive environment.

Qualifications

• Knowledge of FDA regulations and ICH GCP is essential.
• Strong skills in data utilization and complex problem solving required.

Responsibilities

• Oversee clinical research study protocols with an emphasis on quality.
• Develop and disseminate clinical research education as needed.
• Conduct meetings to share quality assurance findings.

Skills

FDA regulations

ICH GCP

data utilization

complex problem solving

critical thinking

resource management

communication

writing skills

Job description

The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research, and patient care. Tomorrow’s discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities.

In the role of a Clinical Research Quality Assurance Specialist II, you will be working in our Cancer Center.

Purpose

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 specialist will assist in logistical and operational feasibility assessments, coordinate the implementation of research projects, and handle the day-to-day administrative activities of the program. They will also provide support to teams to facilitate the achievement of the program’s goals.

Primary Functions

1. Perform quality assurance and oversight of research protocols of higher complexity.
2. Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
3. Develop departmental policies, procedures, and guidelines.
4. Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure compliance.
5. Conduct meetings to disseminate quality assurance findings.
6. Work with teams to resolve clinical research non-compliance through root cause analysis, corrective, and preventative action plans.
7. Assist with the development and implementation of processes to ensure efficiencies between the CTO and collaborating departments. Utilize CTO quality improvement tools and process control to facilitate improvement of systems and processes.

Knowledge – Skills – Abilities

Fundamental knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures. Skills include data utilization, complex problem solving, critical thinking, resource management, communication, and writing skills.

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