Clinical Research Coordinator
Clinical Research Coordinator, University of California at San Francisco, San Francisco, California
Submitted by Roger Evans on Fri, 01/07/2011 - 00:30.Clinical Research Coordinator, University of California at San Francisco, San Francisco, California
Submitted by Roger Evans on Fri, 01/07/2011 - 00:28.The coordinator is responsible for the planning, implementation and daily operation of a group of drug/device trials within this therapeutic area. Reporting to the Clinical Trials Manager for the ILD Program (Archer Eller), the coordinator is responsible for the overall day-to-day operations of these clinical research trials; will also perform other duties as assigned.
In-depth knowledge of the policies and procedures of the FDA with respect to investigational new drug application and approval is required to obtain FDA approvals and carry-out protocols; in-depth knowledge of University guidelines, IRB/CHR requirements, FDA regulations, and Good Clinical Practices is required to carry out safe and appropriate research with human subjects.
Research Coordinator, RN – Hepatology, Rush University Medical Center, Chicago, IL
Submitted by Roger Evans on Mon, 03/01/2010 - 08:12.Research Coordinator, RN – Hepatology,
Job Summary:
The support you deserve is here.
Today, our nurses are doing amazing work. Tomorrow, anything is possible. That’s because at
Under
the general supervision of the senior clinical research coordinator
(SRC), you will initiate, implement and coordinate all aspects of
multiple abdominal transplant clinical trials. Screening, enrolling and
evaluating kidney, kidney/pancreas and liver post-transplant patients;
serving as a liaison between research patients and physicians; and
acting as a resource for research patients and other transplant staff
will also be expected.
The research nurse is an
Duties And Responsibilities:
Coordination of Clinical Studies
· Collaborates with members of the transplant team to increase study patient volume/population.
· Working
collaboratively with the Senior Research Coordinator (SRC), develops
and negotiates all budgets for study protocols, processes the budgets
and the research contracts with the IRB (Investigational Research
Review Board) for the development of funds.
· Working
collaboratively with the SRC, maintains and monitors a record of all
study-related expenses and revenue by individual study.
· Reviews
and becomes familiar with all protocols, and initiates study start-up
activities including study initiation meetings with sponsors,
preparation of research patient charts, source document design,
laboratory flow sheets, scheduling of patient protocol visits, and
outside monitor site visits.
· Develops
patient information sheets and processes all paperwork for the IRB,
including paperwork needed for the study approval and related
correspondence during the study.
· Organizes
patient recruitment activities including the screening of patient phone
calls. Evaluates patients for study qualification in accordance with
protocol inclusion/exclusion criteria by using clinical expertise and
knowledge.
Reviews study procedures with patients and obtain informed consent.
· Arranges physical examinations, medical and social histories and other clinical evaluations.
· Dispenses study medication under the supervision of the physician.
· Draws blood specimen by way of venipuncture, starts IV's, and administers EKG's when required.
· Ensures
that all study drugs are correctly labeled, packaged, dispensed and
accounted for. Acts as liaison with hospital pharmacy in studies where
medications are accounted for by pharmacy.
· Orders
and reviews appropriate laboratory, x-ray and other diagnostic
examinations. Notifies principal investigator of any abnormal values or
adverse events. Follows up with patients as required. Communicates
serious adverse events to sponsors and the IRB in accordance with the
protocols.
· Schedules
study reviews with sponsor monitors, arranges access to all patients'
records for review. Promptly responds to sponsor queries and makes
corrections as required.
· Closes out completed studies in accordance with FDA, sponsor and center regulations and procedures.
· Works
collaboratively with SRC and Corporate Compliance Auditors to provide
all required documentation during periodic audits (i.e., patient
charts, study enrollment forms, protocol visit tracking forms, lab/test
requisitions, billing instruction forms, etc.).
· Assist
SRC with preparing weekly progress reports (via e-mail) to the
Principal Investigators, Medical Director and the Practice
Administrator.
Qualifications:
· Requires RN, BSN preferred, with at least 2-4 years clinical research experience.
·
· Yearly CPR Recertification.
Join Rush and experience your career the way it should be.
Contact:
Please apply online at www.jobsatrush.com, job code 2009-1758. EOE M/F/D/V
James Farris
Sr. Human Resources Consultant
1653
E-mail:James_M_Farris@rush.edu
Web Site: http://www.jobsatrush.com
Identifiers:
Main Category: Research
Subcategory: Clinical Research Coordinator
TPDC Position ID: ILPL-2010-0006
Position ID or Job Requisition No: 2009-1758
UNOS ID or Other ID: ILPL
City:
State/Province:
Country:
Date Posted: 03-03-10
