Regulatory Coordinator

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

Overview

Join a Legacy of Care - Delivering over 50 years of Healing and Hope

For over five decades Cancer Care Northwest has been the Inland Northwest's premier cancer center, providing an integrated approach to the diagnosis, treatment and healing of cancer and blood-related diseases.

Our collective passion to fight against cancer is what motivates and inspires us every day and is the reason Cancer Care Northwest has become the Inland Northwest's premier cancer center. We provide comprehensive, innovative, compassionate, integrated care throughout each patient's journey. We are searching for dedicated professionals who share our passion in saving lives. Are you searching for better work-life balance? Join us in our mission to save lives.

Position Overview:

Under minimal supervision, is responsible for overseeing the regulatory management of industry or federally sponsored or investigator-initiated research studies. This includes the rules and regulations concerning Code of Federal Regulations, Good Clinical Practice and other regulations that govern clinical research studies. This may include, preparing, facilitating, coordinating, and submitting documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research to the IRB central or local and IBC to assure the protection of human subjects in research for all CCNW trials. May assist with data completion and monitoring activities along with Quality assurance projects. Supports and adheres to the Cancer Care Northwest Compliance Program, to include the Code of Ethics and Business Standards.

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.

Qualifications

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

It is preferred an individual has:

• Regulatory experince in clinical research
• Oncology experience

Physical Demands

• Regularly: stand, walk, grasp, reach, talk, and hear
• Occasionally: lift to 40 pounds, pull/push up to 40 pounds, carry up to 40 pounds, bend, and stoop/crouch
• Vision: clearly see up to 5 feet with or without corrective lenses

Work Environment

• not be exposed to any workplace environmental conditions caused by extreme noise, heat, cold, workplace hazards, or atmospheric dust/fumes/vapors/mists
• be exposed to blood borne pathogens
• be exposed to toxic or caustic chemicals
• be exposed to ionizing radiation, medical preparations, and other conditions common to an oncology/hematology clinic environment

Salary DOE

Salary DOE - $25.33 - $36.73

Benefit Information

https://careers.usoncology.com/benefits