Clinical Trials Regulatory Coordinator

The US Oncology Network; Spokane (WA); On-site; USD 35,000 - 51,000; Full time

Job summary

Cancer Care Northwest in Spokane, WA is seeking a Regulatory Affairs professional to oversee the regulatory management of various research studies. You will coordinate the submission of regulatory documents, ensure patient safety, and maintain study information for physicians and staff.

The role involves interfacing with sponsors, IRB/IBC coordinators, and ensuring compliance with GCP, ethics, and institutional requirements. Bachelor’s degree required; oncology experience preferred.

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 IRB forms, 1572 forms, financial disclosures, annual reviews, amendments, INDs, device-related submissions, safety reports, and continuing reviews.
• Organize and maintain up-to-date clinical trial information and study documents for presentation to physicians and staff.
• Communicate with sponsors, study staff and IRB Coordinators regarding document modifications and revisions.
• Track staff training to applicable regulatory requirements including GCP, human subjects’ protection, hazmat training, and study-specific training.
• Help develop CCNW SOPs to ensure staff understanding of compliance and safety.
• Demonstrate attention to detail and ability to multi-task to meet deadlines.
• Demonstrate conflict resolution and superior customer service in stressful situations.
• Work independently and as part of a team.

Skills

Regulatory knowledge

Proficient with MS Office

Oncology experience

Education

Bachelor’s degree or equivalent

Job description

Cancer Care Northwest in Spokane, WA is seeking a Regulatory Affairs professional to oversee the regulatory management of various research studies. You will coordinate the submission of regulatory documents, ensure patient safety, and maintain study information for physicians and staff.

The role involves interfacing with sponsors, IRB/IBC coordinators, and ensuring compliance with GCP, ethics, and institutional requirements. Bachelor’s degree required; oncology experience preferred.