| Position Summary: Rutgers, the State University of New Jersey is seeking a Drug Safety Clinical Trials Specialist for the Office of Human Research Services at Rutgers Cancer Institute of New Jersey. The primary purpose of the Clinical Trials Specialist, Drug Safety position is to manage the Institutional Serious Adverse Event (SAE) activities, monitoring and reporting to the Institutional Review Board, regulatory agencies (i.e., NCI, NIH, and FDA), and industry sponsors. This individual will monitor and apply Federal regulatory guideline and guidance's pertaining to adverse event reporting. Other key responsibilities include oversight of IND review/reporting and analyzing SAE data for trends and for reporting compliance on research protocols performed at the Rutgers Cancer Institute of New Jersey. Among the key duties of this position are the following: - Manages the activities related to the collection, processing, follow-up, analysis and regulatory reporting of deviations, adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational drugs.
- Reviews and processes adverse events reported by Investigators following departmental policy and procedures and guidelines for maintaining regulatory compliance.
- Works with Investigators and staff to generate concise, accurate and well-written case narratives.
- Ensures timely submission of reports to regulatory agencies in accordance with applicable regulations and that all inquiries
from the FDA and other drug regulatory agencies are responded to in a timely manner. - Performs risk and quality function on adverse event reports.
Minimum Education and Experience: - Bachelor's Degree in a related field plus a minimum of (3) years' experience in clinical research regulatory affairs.
- Relevant education and qualification in Science, Medical or Pharmacology disciplines (nursing preferred).
Required Knowledge, Skills, and Abilities: - Proficiency of computer skills, including a diversified knowledge of software packages such as Word, Excel, in addition to Oncology Collaborative Research Environment (Oncore) database experience.
- Clear understanding of Food & Drug Administration (FDA), Office of Human Research Protections (OHRP), National Institutes of Health (NIH) and Health Insurance Portability & Accountability Act (HIPPA) regulations, possess a considerable understanding of Good Clinical Practice (GCP) guidelines, institutional guidelines and SOP's set forth by CINJ and Rutgers.
- Capable of independent decision-making, and multitasking.
- Excellent organization, communication and interpersonal skills, hold him/herself accountable to high standards of professional excellence, be able to maximize resources, and seek and accept personal and professional responsibility.
Preferred Qualifications: - Master's Degree in a related field.
- Relevant education and qualification in nursing.
- Clinical research project administration experience in the pharmaceutical industry.
Posting Number: 21ST0217 Location: Downtown New Brunswick |
