·Quality Assurance Monitoring:
Develop comprehensive quality assurance 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 quality assurance 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.).
Develop and provide quality assurance training and consultation for faculty, staff, and affiliate sites. Provide regulatory training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned.
·Clinical Trial Protocol Development and Implementation:
Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Coordinate the development of regulatory sections 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.
·Data and Documentation:
Review and analyze quality assurance-related data (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation for patients enrolled in clinical trials. Assist in development and monitoring of clinical trial indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures.
Excellent problem-solving, interpersonal, written and organizational skills required.
Knowledge of hematology, oncology, and/or bone marrow transplant clinical settings. Knowledge of medical terminology and anatomy.
Knowledge of clinical trials data management systems.
Strong organizational skills and attention to detail, communication and interpersonal skills, and professionalism required.
Computer literacy in MS Word, Excel, and PowerPoint. Knowledge of electronic data capture/clinical study tracking systems. Experience in clinical research quality assurance or in clinical research monitoring and/or auditing.