IND Safety Coordinator/Regulatory Affairs Specialist
University of California San Francisco - San Francisco, CA

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The Comprehensive Cancer Center
The UCSF Comprehensive Cancer Center (CCC) is an interdisciplinary non-ORU Center. As part of an elite group of NCI-designated Cancer Centers, the overarching goal of the Comprehensive Cancer Center is to shepherd new approaches to cancer prevention, detection, and treatment into clinical and population settings, where they can be tested and evaluated. The CCC is an integral part of an elite network of only 42 NCI-designated Comprehensive Cancer Centers nationally and is supported by a National Cancer Institute Cancer Center Support Grant (CCSG). More than 230 faculty and other academic staff from all four schools are members of the UCSF Helen Diller Family Comprehensive Cancer Center.

The Investigational Trials Resource (ITR) is a shared resource for all UCSF investigators and supports cancer clinical trials. The ITR has a Clinical Research Support Office (CRSO) which is responsible for all the regulatory management of clinical studies: protocol development for investigator sponsored trials (IST’S); submissions to the UCSF Committee on Human Research (CHR) for both pharmaceutical and investigator sponsored trials, and submissions to the FDA for investigator Investigational New Drug (IND’s) applications.

Job Overview
The IND Safety Coordinator/Regulatory Affairs Specialist supports investigators with regulatory submissions to the CHR, FDA and other regulatory committees/agencies as required and processes and maintains records of post approval reporting of pharmaceutical IND Safety Reports, Investigator Brochures, and other Safety Related documents. The IND Safety Coordinator/Regulatory Affairs Specialist will work with the CRSO regulatory staff to ensure timely reporting and that informed consent changes are submitted to UCSF Committee on Human Research (CHR).

The IND Safety Coordinator/Regulatory Affairs Specialist will maintain a database of all received IND safety reports by drug/ date and manufacturer number and provides this information to the Regulatory Affairs Specialist for all annual reviews. In addition the IND Safety Coordinator/Regulatory Affairs Specialist will complete data entry and document upload into the HDFCCC electronic database, real-time filing of all regulatory approvals, and post-approval document dissemination to study team and works with the Clinical team to review IND safety letters as needed for pharmaceutical companies and internal/external auditors to review.

About UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.

Required Qualifications
• Bachelor’s degree in health and or biological sciences related field
• One year experience in clinical research
• Working knowledge of medical terminology
• Ability to independently identify problems and effectively offer solutions to problems
• Proven ability to work collaboratively in a team environment
• Proven proficiency in word processing and data bases
• Ability to sit and work at a computer for long periods of time

Physical Demands: requires sitting; standing; walking; squatting; bending; waist twisting; kneeling; climbing stairs; reaching up to shoulder height; reaching above shoulder level; carrying/lifting 20 pounds; pushing/pulling 20 pounds; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper and lower extremities; differentiate color.

Note: Fingerprinting and background check required.

Preferred Qualifications
• One year experience in oncology

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