Working title:

Research Program Manager

Official title:

RESEARCH PROG MGR I(P70NS)

Degree and area of specialization:

BS/BA required, health-related field preferred. Management experience and/or training desired.

Minimum number of years and type of relevant work experience:

Clinical drug experience preferred. Experience with IRB submissions, budget development and budget negotiations desired. Ability to work with medical faculty to facilitate research in a growing section of medicine is required. Familiarity with UW budget and regulatory policies is a plus.

Principal duties:

-Ongoing identification, recruitment and development of research studies/funding for the GI and Hepatology Section from pharmaceutical companies, foundations, NIH, other medical centers, funding databases or our own investigators.

-Evaluate appropriateness of protocols, budgets and target populations to our research site. Make recommendations to faculty.

-Preparation and processing of contract, IRB, FDA and sponsor regulatory document filings for each study run through this office for the life of the study.

-Prepare and negotiate all study budgets, initiate requisitions and invoices and track accuracy of receipts, expenditures and encumbrances in the accounting systems.

-Supervise accounts with the assistance of section business manager.

-Plan, track and facilitate progress of each research study from planning through implementation and closure.

-Ensure and monitor all faculty, fellows and staff certifications regarding licensure, conflict of interest, human subjects research and HIPAA training, biosafety certifications, sponsor-required training and registration of research databases to maintain research unit compliance with regulations governing research sites.

-Maintain security and privacy of research office related to patient related information, sponsor proprietary information and research databases.

-Continuing education on latest government, NIH, state, UW and hospital regulations of research activities by attending research-related seminars and monthly meetings offered by those entities.

-Train and supervise any other study coordinators, LTEs or student helpers working in the research office.

-Initiate/maintain collaborative relationships with UWHC and UW departments and services (about 20 different ones) in planning and implementing studies at this site.

-Develop and maintain office systems for implementation of protocols, including template forms for data collection, invoicing, advertising, supply inventories and recruitment mailings.

-Manage sponsor visits, including qualifying, initiation, monitoring and closure of studies.

-Act as a clinical study coordinator for specific studies doing protocol-specific and patient-focused patient recruitment, eligibility screening, chart abstraction, consenting, patient education, lab processing, documenting side effects, medical record charting, advising providers on protocol requirements, taking 24/7 call by pager, completing data forms or data entry, completing data queries and filing serious adverse event reports.

TO ENSURE CONSIDERATION

Application must be received by: JUNE 25, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #59319 to