ONCOLOGY RESEARCH COORD II PRN

COOPER PEDIATRICS; Camden (NJ); On-site; USD 52,000 - 70,000; Full time

Job summary

Cooper University Health Care in New Jersey seeks an Oncology Research Coordinator I to provide oversight of oncology clinical studies, focusing on Quality of Life and specimen trials, while supporting study start-up and regulatory processes.

This entry-level role collaborates with sponsors, IRB, and Regulatory/Operations teams to maintain regulatory binders, track documentation, and coordinate site visits and audits.

Qualifications

• 3-5 Related experience
• Bachelor Degree Preferred

Responsibilities

• Oversight of oncology clinical studies, managing Quality of Life and specimen trials.
• Learning and progressing to manage oncology treatment trials.
• Work with sponsors during study start-up to prepare regulatory documents and maintain study binders.
• Coordinate IRB submissions, amendments, continuing reviews, and adverse event reports.
• Provide updates to Regulatory and Operations teams on study status.
• Maintain delegation of authority logs and ensure staff training on protocols.
• Coordinate site initiation visits, monitoring visits, and close-out visits; prepare post-visit documents.
• Maintain tracking for protocol paperwork and coordinate FDA submissions and audits.

Education

Bachelor degree preferred

Job description

About us

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.

Short Description

Oncology and Research are specialized and require unique skill sets. Realigning our MD Anderson Research Department at Cooper University Health Care 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 the Oncology Research Coordinator I provides the oversight of clinical studies in the oncology setting managing Quality of Life and specimen trials, while continuing to learn and advance in experience to manage oncology treatment trials. This is an entry level position.

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.

Experience Required

3-5 Related experience

Education Requirements

Bachelor Degree Preferred