$28.34 - $38.12 / hourly; not specified; not speci...
Federal, state, local regulatory compliance
Maintain program regulatory files
Submit protocol amendments and reports
The Coordinator-Oncology Regulation Affairs researches and ensures compliance with all Federal, State, local and other regulatory bodies
Job Summary
The Coordinator-Oncology Regulation Affairs researches and ensures compliance with all Federal, State, local and other regulatory bodies.
This role is responsible for maintaining all program regulatory files and documents, and submitting all protocol amendments, notices, suspensions, terminations, safety reports, and related protocol documents to the appropriate regulatory bodies within the expected timeframes.
The company's mission is to continue the teaching and healing ministry of Jesus Christ, with core values of compassion, excellence, humility, integrity, justice, teamwork and wholeness.
Matching Summary
The Coordinator-Oncology Regulation Affairs researches and ensures compliance with all Federal, State, local and other regulatory bodies.
Salary
$28.34 - $38.12 / hourly; Not specified; Not specified
Skills & Requirements
Must-have
Federal, State, local regulatory compliance
Maintain program regulatory files
Submit protocol amendments and reports
High level of confidentiality
Ethical integrity
Attention to detail
Nice-to-have
Team player yet work independently
Work calmly under pressure
Recall information with accuracy
Critical independent thinking
Make quick and informed decisions
Key Requirements
Associate’s Degree in related field
Minimum of two years healthcare setting
Oncology or clinical research experience
Drafting or writing clinical documents experience
Current Certified Clinical Research Coordinator (CCRC)