USACares Jobs

Job Information

Cooper University Hospital CLINICAL RESEARCH COORD II- MD ANDERSON in Camden, New Jersey

JOB DESCRIPTION- CRC II

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.

MINIMUM QUALIFICATIONS

Bachelors Degree preferred.

Minimum 3-5 years of clinical research experience required.

Required License/Certifications/ Registration:

MA, LPN, Phlebotomy or CRCC preferred.

Other Qualifications:

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

Scheduled Days / Hours: Monday to Friday 8am to 4:30pm

Requisition: 53618

Department Name: CRI MED Hem Onc 900 Cent Blvd

External Company Name: Cooper University Hospital

External Company URL: cooperhealth.org

Street: 2 Cooper Plaza

DirectEmployers