Working title:

CLINICAL RESEARCH SPECIALIST - CARBONE CANCER CENTER

Official title:

RESEARCH SPECIALIST(T16DN)

Degree and area of specialization:

BA/BS required.

Minimum number of years and type of relevant work experience:

A minimum of 2-4 years experience in clinical research required. Experience with research methodology and regulatory requirements a must. Working knowledge of databases strongly preferred.

Principal duties:

The Research Specialist will join the UW Comprehensive Cancer Center (UWCCC) Clinical Research Central Offices (CRCO). The CRCO functions as a shared service of the UWCCC whose mission is to oversee and facilitate all multidisciplinary oncology clinical research conducted at the UWCCC. Under the direction of the CRCO Program Manager, the Research Specialist will serve as the Quality Assurance and Monitoring Specialist for the UWCCC. The incumbent will apply knowledge of clinical research regulations and study-specific guidelines to carry out internal audits and quality assurance reviews for all clinical research conducted at the UWCCC. The incumbent will work closely with the Assistant Director of Clinical Research to ensure compliance throughout the Cancer Center regarding Federal, UW and UWCCC requirements. The incumbent interfaces with other departments within the hospital and clinics in order to ensure that UWCCC policies and procedures are properly followed. Specific duties are listed below with other duties as assigned.

1. Serve as the Quality Assurance (QA) and Monitoring Specialist for the UWCCC Clinical Research Central Offices (CRCO).
2. Act as Lead Auditor for UWCCC Audit Team for both Internal Audits and Quality Assurance Reviews. Schedule, facilitate and oversee audits with individual research groups within the Cancer Center.
3. Responsible for developing and implementing quality assurance and auditing education and training sessions for UWCCC and its affiliate's clinical research staff.
4. Develop and implement ongoing educational sessions focused on training staff to participate in audits under the incumbent's leadership.
5. Ensure QA of Protocol data within the UWCCC ONCORE Database.
6. Develop and implement system for tracking and monitoring Investigational New Drug (IND) applications held by UWCCC Principal Investigators.
7. Develop and implement tracking and monitoring of all Investigator-Initiated Trials (IIT) at the UWCCC.
8. Assist in updating and implementing Standard Operating Procedures for all UWCCC clinical research monitoring and quality assurance functions.
9. Participate in external audits of clinics within the UWCCC Affiliate Network.

The Research Specialist is expected to follow the policies, procedures, guidelines, and standards for excellence and professionalism established by the UWCCC and the University of Wisconsin. Additionally, this position will assure that all clinical and laboratory research activity adheres to the Code of Federal Regulations and ICH guidelines.

TO ENSURE CONSIDERATION

Application must be received by: AUGUST 04, 2008

HOW TO APPLY:

Unless another application procedure has been specified above, please send resume and cover letter referring to Position Vacancy Listing #59569 to