Functions as the lead oncology clinical trials auditor on approximately 25 - 30% of the audits.
Writes audit reports and enters audit reports into the CTMB Audit Information System. As necessary, assists with scheduling site audits and assisting volunteer auditors with logistical planning of audits
Evaluates institutional audit responses. Requests follow-up on any insufficient responses and evaluates any additional information submitted.
Advises oncology clinical trial sites regarding corrective action plans for improvement of the institutional clinical trial program, including changes to the policies and procedures of the research and regulatory offices, institutional resources and responsibilities of research personnel.
Assists Audit Program Director to determine training needs for auditors and institutional personnel based on audit trends analysis. Develop and implement training programs for auditors and institutional personnel, including workshops, online training modules, job aids and on-the-job training of new auditors.
Ensure consistency of audit policy interpretation and application by all audit committee members and ad hoc auditors.
Assists with review of regulatory compliance documents and participates in activities related to FDA inspection readiness for Alliance oncology registration trials.
Review changes to local informed consent forms, including changes to the risk sections. Respond to regulatory-related inquiries from sites.
Other duties as necessary to ensure compliance with the Alliance Audit P&P, Good Clinical Practice, CTMB Guidelines, and Pharmaceutical Management Branch Guidelines
Plans and executes internal and external audits and activities to support regulatory agency inspections.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Â Performs other related work as needed.
A minimum 2 years of regulatory compliance experience and/or clinical trials monitoring/auditing
Four â“ five years of relevant clinical trials auditing experience
Nursing or other clinical experience
Manage interpersonal relationships and interact/communicate with clarity, tact and courtesy with internal and external personnelÂ
Excellent oral and written communicate skills
Excellent organizational and prioritization skills
Ability to work effectively as part of a team and independently with minimal supervision.
Strong ability to work under pressure and coordinate multiple tasks.
Highly detail oriented. Requires ability to manage time, multi-task, problem solve and communicate effectively
A minimum 30-40% travel is required to conduct Alliance audits and to Alliance Committee and Group Meetings.
Cover Letter (preferred)
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Internal Number: JR10575
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