Senior Clinical Trials.gov Compliance Specialist

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Compliance and Education
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22002524 Requisition #

The Human Subjects Office, at the University of Iowa is seeking a Senior Clinical Trials.gov Compliance Specialist.  This position will act as education and compliance expert with regard to ClinicalTrials.gov, federal regulations, Institutional Review Board (IRB) requirements, and University of Iowa policies and procedures for the protection of human subjects involved in research. They will develop and coordinate procedures and programs to enhance investigator understanding and compliance with ClinicalTrials.gov, the HawkIRB application process, and Institutional Review Board (IRB) policies and procedures.

For additional information and a detailed job description, please visit the departmental website at:
https://research.uiowa.edu/office-vice-president-research/open-positions

About the Human Subjects Office
The Human Subjects Office (HSO) was established by the Office of the Vice President for Research to provide administrative support for the University of Iowa Institutional Review Boards. An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has three such review boards, each consisting of faculty, staff, and representatives from the Iowa City community.

 

Qualifications:

Education or Equivalency Required

A bachelor’s degree in a health-related or clinical field (such as nursing, biomedical sciences, medical laboratory science, radiation sciences, or human physiology) at the bachelor’s level, or an equivalent combination of education and experience.

Required Qualifications

  • Current and relevant experience in human subjects' research (typically 1-3 years).
  • Current and relevant experience (typically 1- 3 years) with analysis and reporting of clinical trial data (randomized clinical trials and/or complex clinical trials preferred), including standard mathematical concepts and statistics.
  • Demonstrates knowledge of federal and state regulations governing clinical research, and Good Clinical Practice (GCP) guidelines.
  • Demonstrates ability to communicate for effective relationships; ability to establish productive working relationships across a variety of departments.
  • Occasional in-state and out-of-state travel is required to attend conferences and meetings.
  • High level of proficiency in computer software applications including Microsoft Office suite and Internet and demonstrated ability to learn an electronic reporting system and teach other users.


Desirable Qualifications

  • Knowledge of academic and/or higher education institutional, and federal regulations regarding the protection of human subjects participating in research including; HIPAA, FDA drug, biologic and device regulations.
  • Experience conducting and/or monitoring research involving human participants.
  • Experience in preparing and reviewing materials for NIH grants and publications.
  • A master's degree in a health-related or clinical field (such as nursing, biomedical laboratory science, radiation science, human physiology, behavioral or public health with a clinical/health emphasis)


Position and Application Details and Instructions:
Upload the following required documents and mark them as a “Relevant File” to the submission:

  • Cover Letter
  • Resume


Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be subject to a criminal background check, and verification of academic credentials. Up to 5 professional references will be requested at a later step in the recruitment process.


Contact:  Sarah Tillman (sarah-tillman@uiowa.edu)
 

Equal opportunity/affirmative action employer


The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.


Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu.  For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.

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