CLINICAL RESEARCH COORD II- Regulatory Coordinator

Location US-NJ-Camden
Job ID
54639
Category
Professionals
Shift
1
Type
Full Time
Department Name
CRI OBGYN Gynecol 900 Cen Blg1

Short Description

 

CRC II- AT MD ANDERSONJOB DESCRIPTION – Regulatory Coordinator

 

MD Anderson Cancer Center at Cooper is South Jersey’s leading cancer center. Partnered with the nation’s leading cancer center – MD Anderson Cancer Center in Houston, Texas – MD Anderson at Cooper takes a disease-site, multidisciplinary approach to cancer care, with an entire team of cancer experts working together to provide comprehensive, collaborative care for each patient.
The Research Department at MD Anderson Cancer Center at Cooper is excited to welcome a Regulatory Coordinator to our team. The Regulatory Coordinator will serve in a critical role to manage the regulatory components of the Cancer Center’s industry-sponsored/pharmaceutical clinical research study portfolio. This is a dynamic position that involves maintaining regulatory compliance and audit readiness.
The Regulatory Coordinator will:
• Work with sponsors during the study start-up process to prepare the regulatory documents and maintain the studies’ regulatory binders.
• 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.
• Maintain the delegation of authority logs 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.
The Research Department at MD Anderson Cancer Center is comprised of a team of research professionals including managers, supervisor, clinical research coordinators, regulatory coordinators and data managers and that reports to the Assistant Vice President of Oncology Services with guidance from the medical Director of Clinical Trials. The position will report to the Manager Research Administration. The department manages a portfolio of clinical trials and research studies across cancer disease sites that include radiation oncology, surgical oncology, and hematology oncology treatment protocols as well as bio specimen and retrospective chart review research studies. The portfolio includes industry sponsored and federally-funded studies as well as studies through the MD Anderson Cancer Center Network that are available at Cooper.

Special Requirements

MINIMUM QUALIFICATIONS


Bachelors Degree preferred.


Minimum 3-5 years of research experience required.


Required License/Certifications/ Registration: CRCC preferred.


Other Qualifications: Basic understanding of Microsoft Excel, Outlook and Word.

 

Experience using multiple central IRB platforms (ex. Advarra, WIRB) and Good Clinical Practice training preferred.

 

 

Scheduled Days / Hours: M-F 8 to 4:30

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