Clinical Research Quality Assurance Specialist II

4 weeks ago


WI United States Medical College of Wisconsin Full time
Job Title: Clinical Research Quality Assurance Specialist II

We are seeking a highly skilled Clinical Research Quality Assurance Specialist II to join our team at the Medical College of Wisconsin (MCW). As a key member of our research team, you will be responsible for ensuring the quality and integrity of our clinical research studies.

Key Responsibilities:

  • Perform quality assurance and oversight of research protocols of increasing complexity.
  • 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.

Requirements:

  • Bachelor's degree in a related field.
  • Minimum 4 years of experience in clinical research coordination.
  • Strong knowledge of FDA regulations, ICH GCP, and institutional policies and procedures.
  • Excellent communication and writing skills.

Why Join MCW?

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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