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Senior Clinical Research Analyst – Tumor Institute
ProvidenceSenior Clinical Research Analyst preparing and submitting regulatory documents for research studies at Providence Swedish. Ensuring compliance with IRB and FDA regulations while supporting clinical research activities.
About the role
Key responsibilities & impact- Prepare, facilitate and coordinate, and submit documents required by federal, state and local regulations and institutional requirements relating to the conduct of research
- This includes preparation of all submissions to the IRB to assure the protection of human subjects in research
- FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution
- Lead the work of Research Assistants on a task-basis, if applicable
- Provide education, on-the-job training, set priorities and schedule workflow required to support project objectives
Requirements
What you’ll need- Bachelor's Degree or five or more years of education or experience in clinical research and regulatory affairs may be accepted in lieu of the degree requirement
- 5 years of experience in healthcare, research or clinical setting
Benefits
Comp & perks- Health care benefits (medical, dental, vision)
- 401(k) Savings Plan with employer matching
- Life insurance
- Disability insurance
- Paid time off (paid parental leave, vacations, holidays, health issues)
- Voluntary benefits
- Well-being resources
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IRB submissionsFDA submissionsinvestigator 1572 formsinvestigational new drug applicationsdevice submissionsEmergency use submissionsHDE submissionsSafety Reportsregulatory complianceclinical research
Soft Skills
leadershiptrainingworkflow managementprioritizationcommunicationcoordinationfacilitationeducation