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| Coordinator of Regulatory Affairs KS Open (J#45406) Title: Coordinator of Regulatory Affairs Company: Univ of Kansas Medical Center Description Coordinator of Regulatory Affairs Employer Name Univ of Kansas Medical Center Department 11601-The University of Kansas Cancer Center Overtime Status Non-Exempt Classification Unclassified Position reports to (Posn Classification Title)Project Manager Length of Employment (Regents Unclassified Jobs Only): Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center. I understand and agree that, if I am employed in a Regents Unclassified position, during the first six months of my employment, I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period. Position Summary This position will be responsible for regulatory responsibilities related to cancer or cancer-related clinical research within the KU Cancer Center (KUCC). Position responsibilities will require excellent written and oral communication skills, excellent organizational skills, working knowledge of database software, demonstrated ability to work indipendently and collaboratively, and previous experience working in an academic medical setting or pharmaceutical company/contract research organization. Requirements Coordinator of Regulatory Affairs Required Qualifications - Bachelor's degree in Biology or Nursing or related field. - Experience may substitute for the degree on a year for year basis. - Excellent written and oral communication skills. - Must possess excellent scientific data documentation skills (experience in protocol design and management preferred.) - Highly literate in computer software related to preparation of documents and workings of data collection databases. - Organized with excellent time-management skills. Preferred Qualifications - Four or more years experience in coordinating clinical research activities. - Experience in oncology trials preferred. Ability to create and manage databases using Microsoft Access. Instructions for applying - Please complete an electronic application and click the "Apply for this Posting" button at the top of the page. THE FOLLOWING FIELDS ARE USED FOR THE POSITION DESCRIPTION - Coordinate new protocol submissions for IRB review. - Liaison between KUCC and sponsors of studies. - Responsible for maintaining and filing all regulatory documentation to ensure protection of subjects and subjects' rights required for cancer clinical trials. - Preparation of adverse event experience reports in absence of study nurse. Enter patient data into screening, eligibility, clinical management database and maintain database as needed. Assist in the preparation of materials for site - visits by sponsors/monitoring committees. Prepare quarterly and annual reports to sponsors for clinical trials. - Monitor patient enrollment in cancer clinical trials. - May perform other duties assigned by supervisor. | |||
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