Employer Industry: Oncology Services

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work remotely with flexible hours
- Contribute to high-quality cancer care for patients in a community setting
- Collaborative work environment with a focus on quality improvement measures
- Engage in meaningful work that impacts patient outcomes in oncology research

What to Expect (Job Responsibilities):
- Assist with critical document collection and maintenance to facilitate timely trial openings and audit readiness
- Communicate and collaborate with central operations to identify and resolve regulatory issues
- Maintain protocol regulatory documents in compliance with local Standard Operating Procedures
- Process local and central Institutional Review Board submissions and monitor Serious Adverse Events (SAEs)
- Facilitate collection of site training documents and coordinate ongoing amendment training

What is Required (Qualifications):
- High School Diploma required
- Minimum of three (3) years of experience in clinical research, regulatory affairs, and/or an oncology-related field
- Experience in Microsoft Office
- Strong communication skills with the ability to multi-task and manage time effectively
- Associate's degree in a clinical or scientific-related discipline preferred

How to Stand Out (Preferred Qualifications):
- Experience working with Sponsor Monitor representatives
- Familiarity with oncology-related regulatory affairs and research protocols
- Previous involvement in quality assurance initiatives within clinical trials
- Understanding of Good Clinical Practice (GCP) and applicable regulations
- Experience in preparing informed consent documents and regulatory packets

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