Working title:

Clinical Research Coordinator-Hem/Onc

Official title:

SR RESEARCH SPEC(T16BN) or RESEARCH SPECIALIST(T16DN) or ASSOC RESEARCH SPEC(T16FN)

Degree and area of specialization:

Bachelor's degree required, preferably in biological, social science or health related field.

Minimum number of years and type of relevant work experience:

Prior experience in a clinical research setting, including knowledge of clinical research principles and regulations, is preferred and/or experience with hematology clinical trials is preferred. Must have strong oral and written communication skills, and excellent interpersonal skills, with the ability to work with patients and researchers. Must be able to work independently using initiative and good judgment.

Principal duties:

This position involves coordinating clinical research trials for the Hematology Disease Oriented Working Group of the University of Wisconsin. The primary duties of this job involve the management of subjects enrolled in clinical research studies. This position will report to the Research Program Manager and work under the general direction of the principal investigator of each research study.
100% Clinical duties include:
* Provide study coordination/data management for clinical trials as specified by the research protocol.
* Assist with identification and recruitment of potential clinical study participants, and verify patient eligibility.
* Maintain knowledge of current active protocols, and facilitate data management with investigator and sub-investigators.
* Collect and manage patient data according to protocol, submit to study sponsor, and ensure protocol and regulatory compliance throughout the project period.
* Complete case report forms & spreadsheets for data collection.
* Maintain direct liaison with the study sponsor on behalf of, or in collaboration with, the principal investigator.
* Assure that all federal, state, local, and university laws and regulations are adhered to, as they relate to the protection of human subjects and to research compliance.
* Secure patient records and source documentation for sponsors and FDA site audits.
* Maintain patient records, including documentation of changes in investigational drug doses, changes in other medications used by the study participant, overall health status of the study participant, and occurrence of drug-related side effects.
* Coordinate with clinic to schedule diagnostic tests including blood tests, radiology tests or other tests that must be completed for the study.
* Assist the principal investigator in obtaining patient consent and documenting the informed consent process to comply with institutional policies and Federal regulations.
* Manage and coordinate follow-up care for study participants and interface with clinic schedulers, outpatient oncology clinic nursing staff, inpatient hospital nursing and pharmacy staff, and the Pharmaceutical Research Center (PRC).
* Prepare for monitor visits conducted by sponsors, evaluate completeness of data in medical records and assist monitors during site visits by providing verification of protocol compliance. Implement sponsor requested changes or respond to written data queries. Apply knowledge gained from site visit/queries to future study activities.
* Work with faculty, residents, and nursing staff to identify and evaluate Severe Adverse Events (SAE). In the event of an SAE, gather required documentation from treating institution. Complete and submit both written and verbal communication to the appropriate regulatory agencies within protocol specified time line. Notify UW IRB and other appropriate parties of SAE and provide requested documentation.
* Provide clinical backup for colleagues.

TO ENSURE CONSIDERATION

Application must be received by: AUGUST 19, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #59684 to