Regulatory Coordinator
About The Position
Cancer Care Northwest is hiring a full-time Regulatory Coordinator, responsible for overseeing the regulatory management of phases I-III industry- and federally-sponsored trials as well as investigator-initiated research studies. This includes the adhering to 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 to the central or local IRB to assure the protection of human subjects in research for all CCNW trials. May assist with monitoring activities along with Quality assurance projects. To perform this job successfully, an individual must meet the minimum qualifications listed below. These qualifications are representative of the knowledge, skill and/or ability required to perform this job.
Requirements
- Must be detail oriented and able to multi-task to meet standard response times and deadlines
- Highly motivated, excellent communication, verbal, and interpersonal skills. Must be able to demonstrate appropriate conflict resolution in stressful situations.
- Superior customer service skills
- Ability to work independently and as part of a team
- Proficient with Microsoft Office
- Bachelor's degree required or equivalent combination of education and experience.
Nice To Haves
- Oncology experience preferred
- Regulatory experience in clinical research preferred
Responsibilities
- overseeing the regulatory management of phases I-III industry- and federally-sponsored trials as well as investigator-initiated research studies
- adhering to rules and regulations concerning Code of Federal Regulations, Good Clinical Practice and other regulations that govern clinical research studies
- preparing, facilitating, coordinating and submitting documentation required by federal, state and local regulations to the central or local IRB to assure the protection of human subjects in research for all CCNW trials
- assisting with monitoring activities along with Quality assurance projects
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
251-500 employees
