ONCOL RESEARCH REG COOR II PRN

At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development.

Discover why Cooper University Health Care is the employer of choice in South Jersey.

Oncology and Research are specialized and require unique skill sets. Realigning the MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston's recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The role of Oncology Research Regulatory Coordinator will serve as the regulatory lead on industry-sponsored, federally funded or MD Anderson collaborative studies maintaining compliance and audit readiness.

Work with sponsors during the study start-up process to prepare the regulatory documents and maintain the studies' regulatory binders throughout duration of study through close out including version control.

Work with the Institutional Review Board to submit initial study applications, amendments, continuing reviews, adverse event reports and other submissions.

Provide regular updates to the Regulatory and Operations team members on where studies are in the review/start-up process, monitoring outcomes, and close out preparation.

Maintain the delegation of authority logs and regulatory documentation for each study and ensure study staff training on each protocol.

Work with sponsors to set up site initiation visits, monitoring visits and study close-out visits and prepare post-visit documents.

Maintains tracking for all protocol related paperwork and collects documents from sponsors for protocol submission and maintenance.
Coordinates FDA submissions and prepares for all research audits.

Must have at least 3-5 years of related experience.

High School