Rutgers, The State University of New Jersey is seeking a Oncology Clinical Research Coordinator III for the Office of Human Research Services (OHRS) at Rutgers Cancer Institute of New Jersey.
The primary purpose of the Oncology Clinical Research Coordinator III position is to assist Cancer Institute of New Jersey's multidisciplinary Oncology Clinical Research Team with conducting clinical trials. Responsible for assisting the clinical research team in overall study coordination, including, but not limited to, preparing for study initiation and activation, acquisition of source documents, record maintenance, preparing study documents, patient registration, coordinating and data entry. Serves as a study liaison with study sponsors and provides assistance with overall study coordination that is compliant with the Food and Drug Administration (FDA), National Institutes of Health (NIH), Code of Federal Regulations (CFR), Good Clinical Practice (CGP) guidelines, Office for Human Research Protection (OHRP), Health Insurance Portability and Accountability Act (HIPAA), institutional guidelines and standard operating procedures (SOPs) set forth by Cancer Institute of New Jersey and RBHS. Understands and meets/exceeds the needs of all customers (patients, families, study sponsors, monitors, auditors, multidisciplinary team, etc.). Demonstrates competency in recognizing the unique needs of patients of all ages, neonate (birth – 28 days), infant (29 days – less than 1 year), pediatrics (ages 1-12 years), adolescent (13 – 17 years), adults (ages 18-64 years), and geriatrics (age 65+ years).
Among the key duties include the following:
Coordinates the initiation and activation of all new clinical trial protocols.
Coordinates the preparation of study tools including but not limited to study binders, medication diaries, eligibility checklists and flow sheets (as required).
In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patients' charts and medical history to confirm protocol eligibility and obtains source documents (i.e. medical record documentation) as needed.
Registers consented research patients with study sponsor (e.g. industry, NCI Cooperative group, etc.) and inputs into Oncore® clinical trials database maintained by Cancer Institute of New Jersey.
Maintains research record (e.g. patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Cancer Institute of New Jersey clinical trials.
Minimum Education and Experience:
Bachelor's Degree in a relevant science or a related field (e.g. public health, healthcare administration).
A minimum of one to three (1-3) years of research related experience, strong research specific knowledge base, solid knowledge of computer software programs such as Excel®, Word®, and/or Access®.
Required Knowledge, Skills, and Abilities:
The ideal candidate will be detail orientated, have excellent organizational, communication and interpersonal skills, hold self-accountable to high standards of professional excellence, be able to maximize resources and be resourceful, seeks and accepts personal and professional responsibility on a continued basis.
Able to function independently and adjust hours to meet job demands.
Applicants may substitute additional related experience such as laboratory, clinical or medical experience for the education requirements on a year-for-year basis.
Understanding of the software program Oncology Collaborative Research Environment (Oncore®).
Association of Clinical Research Professional (ACRP) certification as a Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) or Society of Clinical Research Associates (SoCRA) certification as a Clinical Research Professional (CCRP).
Physical Demands and Work Environment:
Walking, sitting, standing, pushing, pulling, bending and lifting. No special vision requirements. Lifting up to 25 lbs. Possible travel for Investigator meetings. Possible travel to retrieve data from other clinics.
Posting Number: 19ST2101
Location: Piscataway (RBHS)
Internal Number: 88604
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.