Rutgers, The State University of New Jersey, is seeking a Program Development Analyst, (Regulatory Affairs), for the Office of Human Research Services (OHRS) at the Rutgers Cancer Institute of New Jersey.
The Program Development Analyst under the direct supervision of the Manager of Clinical Trials Regulatory Affairs will manage the regulatory activities of the Office of Human Research Services (OHRS). These activities include, but may not be limited to preparation of documents for submission to the Institutional Review Board (IRB), Investigational New Drug (IND) preparation and maintenance, submissions of letters of intent and protocols to be submitted to the National Cancer Institute or pharmaceutical sponsors. The Program Development Analyst will manage and maintain regulatory documents for Cancer Institute of New Jersey investigator initiated, national cooperative group and industry trials. This position will assist in developing and maintaining Standard Operating Procedures (SOPs) that comply with all pertinent regulations to ensure the accuracy and timely of all protocols, consent forms, amendments, annual re-approvals, serious adverse events, and IND safety reports to the IRB.
Among the key duties of this position are the following:
Communicates effectively with CINJ staff, Investigators, Network staff, industry sponsors, monitoring personnel from the national oncology cooperative groups, Cancer Trials Support Unit (CTSU) of the NCI, Food and Drug Administration (FDA), and others.
Facilitates protocol submissions to the CINJ Scientific Review Board (SRB) through the OnCore electronic Protocol Review and Monitoring System (ePRMS) and assures submission of updated Tumor Study Group protocol tree.
Manages the protocol amendment approval process by preparing amendments for submission to the IRB.
Assists the Principal Investigator in preparing the continuing review application and any changes to the informed consent form.
Assists the Principal Investigator in preparing the study closure report.
Collects and tracks all regulatory documentation (site IRB approvals, informed consent forms, CITI certificates, Rutgers Investigator Financial & Other Personal Interests Disclosure Form, Form FDA 1572s, Curriculum Vitae, medical licenses, lab norms, etc. from all participating investigators and from our partner and affiliate sites for all national cooperative oncology groups for which CINJ is lead institution; and through the Cancer Institute of New Jersey Oncology Group network sites that participate in CINJOG assigned studies with Cancer Institute of New Jersey is the coordinating center.
Collects, completes and submits regulatory documentation to various regulatory entities such as Cancer Trials Support Unit (CTSU) for national oncology group protocols.
Reviews quality assurance reports of audits at clinical trial participating sites and follow up on regulatory issues identified. Provides appropriate education regarding any deficiencies.
Minimum Education and Experience:
Bachelor's Degree plus (3) years' experience in clinical research regulatory affairs.
Equivalent experience, education and/or training may be substituted for the education requirements.
Required Knowledge, Skills, and Abilities:
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access PowerPoint and Oncore.
Must have a 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.
Must be capable of independent decision-making, and multitasking.
Must have 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.
Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP) certification.
Clinical research project administration experience in the pharmaceutical industry is also highly desirable.
Physical Demands and Work Environment:
PHYSICALDEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.
Posting Number: 19ST2654
Location: Downtown New Brunswick
Internal Number: 92435
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.