Oncology Research Specialist – Regulatory Affairs & Compliance, Delegation of Responsibility

Essential Functions

• 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.

• Assists with Regulatory and other compliance documentation associated with oncology research projects/clinical trials.

• Participates in the study start-up and maintenance activities, working with the PI
  -Participates in the study start and others on the delegation of research study related tasks.

• Completes and maintains Delegation of Responsibility Logs, Delegation of Tasks

• Log and Signature Profiles for oncology research studies.

• Assures study delegation of responsibility documentation is managed compliantly and maintained in an audit-ready manner.

• Maintains appropriate documentation for assigned studies in accordance to standard procedures.

• Assists in timely filing of documents and maintains electronic data repositories

• 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.

Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in clinical trials.

• Primarily works a remote/home-based setting within the Charlotte regional area.

High School Diploma or GED required; bachelor’s degree preferred, Health/Science preferred. Experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.

Aurora Health Care