Oncology Research Specialist - Regulatory Affairs & Compliance - FT

Advocate Aurora Health is the third-largest nonprofit, integrated health system in the United States, and they are seeking an Oncology Research Specialist to assist with regulatory and compliance documentation for oncology research projects and clinical trials. The role involves maintaining audit-ready documentation, participating in study start-up activities, and ensuring compliance with regulatory obligations.

Responsibilities

• Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials
• Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc
• Participates in the research study start-up activity, working with the PI and others to initiate new research projects within activation timelines
• Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures
• Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections
• Serves as study liaison to the IRB
• Assists in timely filing of documents and maintains electronic data repositories and other electronic systems
• Assists with the development of and maintains process guidelines to ensure procedural compliance
• Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately
• Communicates with research team, sponsors, and IRB on the status of assigned studies
• Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department
• Participates in the study project start-up activity, works with the PI and others to initiate new research projects
• Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner
• Maintains appropriate documentation for assigned studies
• Assists in maintenance of filing systems, data repositories and systems
• Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately
• Obtains required documentation and to assess patient eligibility for research studies
• Contacts local research staff to confirm scheduling of tests/treatments required by protocol
• Obtains and completes data for patients enrolled on clinical trials

Skills

• High School Diploma or GED required
• Must speak/write clearly in English
• Experience in a healthcare setting preferred, especially cancer care and/or clinical research
• Bachelor's degree preferred
• Health/Science preferred
• Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred

Benefits

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

Company Overview

• Advocate Aurora Health is a Healthcare It was founded in 2018, and is headquartered in Milwaukee, Wisconsin, USA, with a workforce of 10001+ employees. Its website is https://www.advocateaurorahealth.org/.

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