Location: Alliance for Clinical Trials in Oncology Chicago Office
1) Directs the operations of Quality Assurance, including regulatory and FDA compliance, and the audit operations for The Alliance for Clinical Trials in Oncology (Alliance).
2) Develops and maintains P&Ps and SOPs for the Alliance Audit Program based on requirements and guidelines from the Clinical Trials Management Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, National Cancer Institute (NIH), the FDA, Clinical Trials Support Unit (CTSU, and the Office of Human Research Protection (OHRP).
3) Manages, trains, and evaluates the Alliance audit staff for audit scheduling, audit functions, and audit report submissions to the CTMB.
4) Serves as a liaison between Alliance and the CTMB, CTSU, and CTEP which often requires national committee participation.
5) Conducts on-site audits according to CTMB and CTEP Guidelines and Alliance P&Ps and creates audit reports for such audits when acting as the audit team leader.
6) Reviews all draft and final Alliance audit reports nation-wide, along with applicable international sites.
7) Oversees institutional audit responses and corrective plans.Â Mentors sites with critical areas from audit findings as well as assesses audit trends and determines needs for strategic planning and/or site and auditor training.
8) Directs the activities as well as leads Audit Committee meetings at bi-annual group meeting.
9) Assesses registration trial findings and trends as well as participates in registration trials and QA meetings to identify areas of risk, protocol violations and non-compliance.
1) Strategic Leadership and interpersonal skills
2) Strong oral and written communication skills
3) Strong Organizational and Analytical skills
4) Strong Project Management and Prioritization skills
5) Ability to work independently as well as part of a team
1) Minimum of 10-15% audit and meeting travel is required.Â Travel to NCI meetings may be needed.Â
2) Masters degree.
1) Minimum of 2 years clinical trials monitoring/auditing.
2)Minimum of five (5) years clinical trials management, quality assurance and/or regulatory affairs experience.
3) Minimum of 2-5 supervisory experience.
4) Significant knowledge of relevant federal compliance laws and regulations.
5) Maintain active Human Subjects and Good Clinical Practice Certificates.
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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