Clinical Research QA Specialist - Pulmonary

Expected Starting Pay Range: $56,846.40 - $72,488.00
Starting pay is based on experience, skills, and equity; exceptions may apply for highly qualified candidates. Additional pay (e.g., shift, on‑call, or weekend differentials) and benefits may apply. Annual pay may vary based on FTE status.

Burnet Campus

Pulmonary Medicine

Day (United States of America)

Full time

40

1

Regular

• Data and Documentation – Review and analyze clinical trial data and related documentation (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation clinical trials. Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures.
• Monitoring – Develop comprehensive data safety monitoring plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements. Prepare and execute monitoring plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity;
  
  verify essential documents are accurate, complete, and maintained; and coordination of applicable follow‑up activities. Assist in the development and implementation of action plans for external monitoring/audit follow‑up. Assist in preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies. Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.).
• Protocols – Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Participate in the development of investigator‑led protocols, e.g., data safety monitoring plans. Develop and maintain SOPs for clinical trials. Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested.
• Training – Assist in developing and providing clinical trial training and consultation for faculty, staff, and affiliate sites. Provide training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned.

• Bachelor's degree in a related field
• 2+ years of work experience in a related job discipline
• SoCRA or ACRP within 18 months of external hire

Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability