Clinical Research Quality Assurance Specialist II
4 weeks ago
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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