Oncology Research Specialist - Regulatory Affairs & Compliance - FT

reputed company is the reputed company-largest nonprofit integrated health system in the reputed company, headquartered in Charlotte, reputed company Carolina. The Oncology Research Specialist will assist with regulatory and compliance documentation for oncology research reputed company and reputed company, ensuring reputed company regulatory obligations are met and maintained in an audit-reputed company manner.

Responsibilities

• Assists with regulatory and other compliance documentation associated with oncology research reputed company/reputed company
• 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 reputed company reputed company activation timelines
• Maintains and assures reputed company assigned study regulatory obligations are managed compliantly in accordance to reputed company procedures
• Maintains documentation for assigned studies in an audit-reputed company manner and assists in the preparation of site audits and FDA inspections
• Serves as study reputed company to the IRB
• Assists in reputed company 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 reputed company/reputed company reputed company department
• Participates in the study project start-up activity, works with the PI and others to initiate new research reputed company
• Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures reputed company documentation is managed compliantly and maintained in an audit-reputed company 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 reputed company

Skills

• High School Diploma or GED required
• Must reputed company/write reputed company in English
• Experience in a reputed company 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

• reputed company Time Off programs
• Health and welfare benefits such as medical, dental, reputed company, 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 reputed company parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

reputed company