Regulatory Project Manager
- Monrovia, CA
What you'll be doing
- Oversee the operation of QA regulatory reviews. Coordinate and train regulatory auditors. Conduct regulatory audits. Develop regulatory educational materials for sites and auditors. Serve as a resource for regulatory questions from COG sites; review of COGQA mailbox queries. Maintain the NCI audit database, which includes scheduling audits on-line, compiling audit findings, entering audit reports, and entering follow-up final reports and action items, as necessary. Participate in review of draft audit reports, works to finalize report in follow up with site and auditors as required. Generate all site letters and response drafts for medical director signature. Maintain audit draft and response review tracking sheet. Track ineligible cases identified at audit, and communicate with study chairs and members as necessary. Assist with review and submission of safety reports to regulatory authorities. Other duties as required and assigned by medical director and manager of QA and regulatory affairs.
What your background should be
- At least 2 years in clinical quality assurance and/or clinical regulatory compliance. Must be able to communicate in writing using correct grammar and punctuation. This require excellent written communication skills and proficiency at conveying complex processes in a clear manner. Must be able to perform basic mathematical computations such as calculating averages and/or percentages as a means of analyzing data. Must be able to analyze compiled results, understand the significance of the average and/or percentages calculated, and develop a recommended course of action. Strong critical thinking and reasoning skills. Strong interpersonal and collaboration skills.
Required Schooling / Training
- Bachelor degree required.
Who is the client company
- Promotes health, well being, and quality of life through research, training, and community building.
- If you are interested in this position, send your resume to firstname.lastname@example.org