Research Regulatory Specialist

Ironwood Cancer & Research Centers has beautiful state-of-the-art integrated Cancer and Women's Centers, with locations strategically located throughout the Valley. Each one provides a superior cancer care environment with a full spectrum of cancer related services for patients. Our multi-disciplinary team approach includes surgical oncology, medical oncology, radiation oncology, women's centers, diagnostic imaging services, social service support, nutritionist, integrative services, and genetic counseling.

Mission Statement

To serve the community by providing quality, comprehensive cancer care which respects the values and needs of each individual.

Position Summary

Responsible for ensuring timely submission of complete, accurate, and neat documents to pharmaceutical sponsors, IRB, and contract research organizations, where applicable. Ensure compliance with training and maintenance of all documentation. Maintain and update site information as required.

Essential

Duties and Responsibilities

• Ensure ongoing maintenance of regulatory documents, IRB reporting and submissions of amendments, renewals, etc.
• Ensure delegation logs are complete.
• Assist with study start up activities such as site contact questionnaires, imaging questionnaires and qualifications, etc.
• Ensure consents and re-consents are done and documented properly in a timely manner.
• Ensure compliance with department standards and all federal regulations and international guidelines of good clinical practice.
• Facilitates and oversees study initiation visits, monitoring visits, closeout visits and audit visit, ensuring all study regulatory documentation and study issues are addressed.
• Assist with and ensure review of IND safety reports
• Manage, update and maintain all curriculum vitae and licenses for investigators and other study staff on delegation logs.
• Manage, update and maintain all local lab certifications and normal ranges.
• Ensure documentation of training is completed on training logs for all investigators, study staff and applicable clinical staff (pharmacy, nursing, etc.).
• Manage, update and maintain records of GCP/Human Subjects Protection, IATA, CPR and other training for investigators and study staff as appropriate.