Working title:

Clinical Research Coodinator

Official title:

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

Degree and area of specialization:

Bachelor's degree in a health or medical sciences field required.

Minimum number of years and type of relevant work experience:

A minimum of one year of recent experience as a research study coordinator working with human subjects in pharmaceutical trials is required. Computer proficiency with Word and Excel is also needed. Knowledge and work experience with gastroenterology, hepatology, and/or clinical research experiece is a plus.

Principal duties:

As a Clinical Research Coordinator, this person will implement and coordinate 6-8 clinical research studies at any one time (drug and disease trials) in the Gastroenterology and Hepatology Section of the Research Office and work as a research colleague of the Gastroenterology and Hepatology Section of the Department of Medicine. This coordinator will work with one other study coordinator and a research manager as part of a collaborative team covering research activities at 3 locations through out the week. Responsibilities of this position are as follows:

Work with Human Subjects (70%): 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 subinvestigators; 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 and spreadsheets for data collection; Maintain direct liaison with the study sponsor on behalf of, or in collaboration with, the principal investigator; Assure 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 participant, overall health status of the participant, and occurrence of drug related side effects; Coordinate with clinic to schedule diagnostic tests including blood tests, radiology tests or other tests that need to be completed for the study; Assist with the PI 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 a 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 and IRB and other appropriate parties of SAE and provide requested documentation.

Data (15%): Document, compile, and transmit confidential personal health information according to FDA, GCP ICAH guidelines collected from and about study subjects to the research sponsor using a variety of coded data capture mechanisms, including electronic systems, according to study protocol and regulatory guidelines. This includes handling, processing, and shipping biological specimens, responding to sponsor data queries, working with sponsor monitors to insure accuracy of the research data collected on each subject.

Faculty/Staff Support (10%): Act as a research consultant by providing protocol specific information regarding eligibility criteria, clinical test/procedures, drug doses, dosage adjustments, adverse event management, and patient monitoring requirements. The coordinator will be responsible for screening referred patients as to eligibility, interviewing patients, collecting their medical and medication histories, collecting blood and stool samples and processing them for shipment, monitoring and documenting clinical test results as well as adverse events in study patients and presenting these to providers for management orders.

Administrative (5%): Assist with a variety of administrative and regulatory activities of the research office, as assigned by the Research Program Manager, including preparing and keeping FDA-required regulatory documents up to date for each study, assisting in reconciling study charges, writing subject informed consents and processing other documentation through the UW system as needed.

Additional Information:

Title prefix and salary determined by years of relevant experience. References will be required and checked. VA Hospital credentialing will include a background check. Access to a car will be necessary at times. Occasional evening and weekend hours required for recruitment and consenting subjects or assisting with subjects who are experiencing adverse effects.

TO ENSURE CONSIDERATION

Application must be received by: JULY 16, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #59599 to