Clinical Trials Regulatory Specialist

US Oncology Network-wide Career Opportunities; 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 regulatory management for industry, federally sponsored, and investigator-initiated studies, ensuring protection of human subjects and adherence to CFR and GCP guidelines.

Under minimal supervision, you will manage IRB/IBC submissions, maintain trial documentation, and coordinate with sponsors and study staff to ensure timely filings and compliant operations within CCNW's compliance program.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Proficient with Microsoft Office.
• Regulatory experience in clinical research preferred.
• Oncology experience preferred.

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.

Skills

Regulatory affairs knowledge

Attention to detail

Communication skills

Education

Bachelor's degree or equivalent combination of education and experience

Tools

Microsoft Office

Job description

Cancer Care Northwest in Spokane, WA seeks a Regulatory Affairs professional to oversee regulatory management for industry, federally sponsored, and investigator-initiated studies, ensuring protection of human subjects and adherence to CFR and GCP guidelines.

Under minimal supervision, you will manage IRB/IBC submissions, maintain trial documentation, and coordinate with sponsors and study staff to ensure timely filings and compliant operations within CCNW's compliance program.