Clinical Research Quality Assurance Specialist II

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

Job summary

An established industry player seeks a Clinical Research Quality Assurance Specialist II to oversee complex clinical research protocols. This role involves ensuring compliance with FDA regulations and ICH GCP, developing departmental policies, and providing essential support to research teams. The position emphasizes quality assurance and operational feasibility assessments, facilitating the achievement of program goals. Join a collaborative environment that fosters innovation and improvement in patient care and research practices, making a meaningful impact on the community's health and well-being.

Qualifications

• Knowledge of FDA regulations and ICH GCP is essential.
• Strong problem-solving and critical thinking skills are required.

Responsibilities

• Oversee clinical research study protocols and ensure compliance.
• Develop and disseminate clinical research education as needed.

Skills

FDA regulations

ICH GCP

problem-solving

critical thinking

communication skills

writing skills

Tools

CTO quality improvement tools

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 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 Clinical Research Quality Assurance Specialist II will assist in logistical and operational feasibility assessments, coordinate the implementation of research projects and 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

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 & process control to facilitate improvement of systems & processes.

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; communication and writing skills.