| Company: | KUMC Research Institute |
| Job Location: |
Kansas City - Wyandotte County |
| Employment Type: | Full Time |
| Salary Range: | Commensurate wtih education and/or experience |
Description: |
| This position will have responsibility for all research administration activities of assigned clinical trials for the Regulatory Support Program Division of the Clinical Research Development Office (CReDO). |
Duties: |
Ensure that protocols, amendments, adverse event reports, investigational drug brochures, continuing reviews and other miscellaneous documents are approved by the Human Subjects Committee (HSC), hospital departments/committees, appropriate federal and regulatory oversight groups, as appropriate. Review the research protocol and prepare study specific consent forms. Prepare appropriate documents needed to obtain approvals. Maintain Research Institute records and files in concert with regulatory requirements. Ensure that all data is entered into the CRA database in a timely fashion.
Prepare and maintain regulatory documents.
Serve as the single contact person from the regulatory Support Program division of CReDO for principal investigators, sponsors, HSC and contract research organizations.
Administer KUMC internal documentation of the trial.
Participate in special projects/events promoting clinical trials to KUMC faculty.
Participate in research education opportunities.
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Qualifications: |
REQUIRED
Bachelors’ degree in life sciences or healthcare related field and prior clinical research experience. Five years of clinical research experience may be substituted for a Bachelors’ degree.
Clinical Research Professional Certification or certification eligible.
Excellent communication, interpersonal, analytical and problem solving skills. Proven presentation and management skills. Creativity. Good judgment. High level of professionalism. Ability to manage multiple projects. Must have excellent computer skills. High proficiency in MS Word. Working knowledge of Access.
PREFERRED
3-5 years relevant experience within a university research administration environment
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