Research Regulatory Affairs Coordinator- Remote
About the position The US Oncology Network is seeking a Research Regulatory Affairs Coordinator to join Texas Oncology. This role will support all TxO Locations and is responsible for the research regulatory and administrative activities of clinical trials for the practice. The position manages all regulatory processes and procedures, independently prepares protocol documents that comply with regulatory and institutional requirements, and leads the development and implementation of quality improvement measures. The coordinator ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) and Texas Oncology Research Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations through OSHA, CDC, and HIPAA. The role also supports and adheres to the US Oncology Compliance Program, including the Code of Ethics Business Standards.
Responsibilities
- Assists with Critical Document collection and maintenance to facilitate the timely opening of trials at the site and audit-readiness through the life of the study.
- Communicates and collaborates with central operations to identify and resolve any regulatory issues.
- Maintains Protocol Regulatory Documents in compliance with local Standard Operating Procedures.
- Maintains Texas Oncology Research systems, including ensuring appropriate access to all staff and sponsor representatives and troubleshooting any issues.
- Assists with local QA Initiatives. Leads development and implementation of quality improvement measures to assist Investigators with protocols and regulations.
- Assists with preparation of Informed Consent Documents and regulatory packets (FDA1572, Financial Disclosures, etc.) for sponsor and IRB submissions.
- Processes local and central Institutional Review Board submissions.
- Monitors and reports SAEs to sponsor/IRB.
- Facilitates collection of site training documents from study initiation visits as well as coordinates and collects ongoing amendment training documents.
Requirements
- High School Diploma required.
- Minimum of one (1) year of experience in clinical research, regulatory affairs and/or an oncology related field required.
- Experience in Microsoft Office
- Must have excellent communication skills, strong ability to multi-task, excellent time management skills.
Nice-to-haves
- Associate's degree in a clinical or scientific-related discipline preferred.
- Experience working with Sponsor Monitor representatives preferred.
- Experience working in clinical research, regulatory affairs, and/or an oncology-related field is preferred.
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