Clinical Research Regulatory Coordinator
2 weeks ago
The Senior Clinical Research Analyst plays a pivotal role in the field of Oncology Regulatory Affairs. This full-time position is focused on preparing, facilitating, coordinating, and submitting essential documentation in compliance with federal, state, and local regulations, as well as institutional standards related to research activities.
Key Responsibilities:
- Ensure the accurate preparation of all submissions to the Institutional Review Board (IRB) to safeguard the rights and welfare of human subjects involved in research.
- Manage FDA-required submissions, which may encompass investigator 1572 forms, investigational new drug applications, and device submissions, including Emergency Use, Humanitarian Device Exemptions (HDE), Safety Reports, and other necessary documents mandated by regulatory bodies or the institution.
- Supervise and guide the work of Research Assistants on a task-oriented basis, when applicable.
- Provide comprehensive education and on-the-job training, establish priorities, and organize workflow to meet project objectives.
Qualifications:
Applicants should possess a Bachelor's Degree or an equivalent combination of education and experience in clinical research and regulatory affairs, with a minimum of five years of relevant experience in a healthcare, research, or clinical environment.
Why Choose Providence?
At Providence, we offer exceptional benefits designed to support your health, professional growth, and financial well-being. Our commitment to our caregivers ensures that you can focus on delivering high-quality care to our patients.
About Providence:
Our mission is encapsulated in our promise: 'Know me, care for me, ease my way.' Working within our organization means being part of a team that values your contributions and supports your career development.
With over 120,000 caregivers across more than 50 hospitals and 1,000 clinics, we are dedicated to advancing healthcare practices and serving diverse communities throughout our regions.
Commitment to Diversity:
Providence is an Equal Opportunity Employer, dedicated to fostering an inclusive workplace where diversity is celebrated, and every individual is valued and respected.
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