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Clinical Research Coordinator II

Rutgers University

Job Description


Details

Posted: 29-Aug-23

Location: New Brunswick, New Jersey

Salary: Open

Categories:


Medical School/Programs
Staff/Administrative

Internal Number: 165877


Position Summary:


Rutgers, The State University of New Jersey is seeking a Clinical Research Coordinator II (CRCII) for the Department of Medicine – Gastroenterology, within the New Jersey Medical School.
The primary purpose of the Clinical Research Coordinator II (CRCII) position is to assist the Gastroenterology and Hepatology research team with conducting clinical trials. The CRCII is responsible for assisting the clinical research team with conducting clinical trials, 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 of Human Research Protection (OHRP), Health Insurance Portability and Accountability Act (HIPAA), institutional guidelines and standard operating procedures (SOPs) set forth by the New Jersey Medical School
Among the key duties of the position are the following:
  • Coordinates the initiation and activation of all new clinical trial protocols. This includes, but is not limited to verifying Institutional Review Board (IRB) and finance/contract approvals. Collaborates with other members of the research team to schedule/prepare agendas for pre-activation, initiation and activation meetings.
  • In collaboration with other members of the research team and/or physician, obtains source documents (i.e., medical record documentation) as needed.
  • Actively recruits and screens study subjects. Assists with reviewing subject medical records for study eligibility.
  • Registers research patients with study sponsor (e.g., industry, NCI Cooperative group, etc.) and inputs into applicable databases.
  • Maintains research record (e.g., patient consent, eligibility, case report forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled to clinical trials.
  • In collaboration with other members of the study team, performs required data entry and data management for assigned studies.
  • In collaboration with other members of the research team and/or physician, completes and submits Serious/Unexpected Adverse Event Forms for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines.

Minimum Education and Experience:

  • Bachelor's Degree in a relevant science. Minimum of two (2) years of research related experience required.
  • Equivalent education, experience, and/or training may be substituted for the degree requirements.

City: Newark

State: NJ

Physical Demands and Work Environment:


PHYSICAL DEMANDS:
  • Standing, walking, bending, sitting, pushing, pulling, and lifting.

WORK ENVIRONMENT:
  • Clinical environment. Possible exposure to blood, excrement, antineoplastic drugs and possible exposure to infectious and communicable diseases. Proper precautions will be taught and are mandatory.

Special Conditions:

  • Able to function independently and work flexible hours including weekends and evenings.
  • May be required to travel.

Posting Number: 22ST1862


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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.
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