Clinical Research Regulatory Coordinator (Oncology)

US Oncology Inc.; Spokane (WA); On-site; USD 34,000 - 51,000; Full time

Job summary

Cancer Care Northwest in Spokane, WA seeks a regulatory affairs professional to oversee the regulatory management of industry- or federally sponsored research studies. You will ensure compliance with CFR, GCP, and related regulations while coordinating IRB/IBC submissions and maintaining study documentation for patient safety.

The role involves interaction with sponsors and study staff, tracking training on regulatory requirements such as GCP and hazmat, and developing standard operating

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Proficient with Microsoft Office.

Responsibilities

• Have knowledge and represent the research program in all regulatory affair requirements, interacting with local, state and federal agencies.
• Submissions of regulatory documents including but not limited to: initial IRB forms, 1572 forms, financial disclosures, annual reviews, amendments, investigational new drug applications, device related trial submissions, safety reports, and continuing reviews. Track submissions and ensure timely filing of documents.
• Responsible for organizing and maintaining up to date clinical trial information, including study protocols and informed consent forms, for accurate presentation to physicians and study staff to ensure patient safety.
• Directly communicates with sponsors, study staff and Institutional Review Board Coordinators as it relates to study specific document modifications and Institutional Review Board requested revisions.
• Tracking staff training to all applicable regulatory requirements including but not limited to GCP, Human subjects’ protection, hazmat ( IATA) training, and all study specific related training.
• Help to create/develop CCNW standard operating procedures to ensure staff understanding of required compliance and research participant safety.
• Must be detail-oriented and be able to multi-task to meet standard response times and deadlines.
• Must be able to demonstrate appropriate conflict resolution in stressful situations.
• Demonstrate superior customer service skills.
• Demonstrate the ability to work independently and as part of a team.
• Any other duty as assigned.

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Cancer Care Northwest in Spokane, WA seeks a regulatory affairs professional to oversee the regulatory management of industry- or federally sponsored research studies. You will ensure compliance with CFR, GCP, and related regulations while coordinating IRB/IBC submissions and maintaining study documentation for patient safety.

The role involves interaction with sponsors and study staff, tracking training on regulatory requirements such as GCP and hazmat, and developing standard operating