Apply Now Clicking "Apply Now" opens the link in a new window.

Job Summary

To provide administrative and research support to clinical research faculty and staff in the division of Pediatric Hematology-Oncology, Clinical Research Office

Responsibilities*

  • Collect and manage patient and laboratory data for clinical research protocols
  • Screen and have oversight for the recruitment of subjects per study protocol
  • Collect specimens, monitor subjects and ensure patient’s response to therapy is adequate to continue on study
  • Obtain simple consents from research subjects
  • Coordinate the handling of study medications
  • Assist in the reporting of test results
  • Design work flow and participate in quality assurance measures and coordinate study site visits
  • Assist in submitting adverse event reports
  • Prepare appropriate reports on each research patient, maintaining and completing the supplied case report forms for investigator and/or sponsor
  • Check study calendar and protocol for completion of study procedures
  • Ensures integrity of specimen management. (collection, processing, shipping/packing, storing, labeling, tracking, etc.)
  • Facilitate audits from sponsor institutions or internally
  • Participate in conferences related to the project and/or its progress
  • Coordinate communication between team members re: opening/closing of protocols, new information/amendments and administrative requests from study sponsors
  • Complete Institutional Review Board (IRB) applications
  • Edit and renew IRB applications
  • Create amendments as required per protocol
  • Correspond with IRB and other core committee staff
  • Generate IRB approved consent forms
  • Submit Data Safety reports to the Data Safety Management Board and IRB
  • Other duties as required and determined by study PI

Required Qualifications*

  • Bachelors's Degree
  • 3 years of clinical research experience
  • Excellent interpersonal and organizational skills
  • Ability to organize/prioritize tasks effectively and efficiently
  • Ability to set goals, promote teamwork and problem solve
  • Excellent computer skills

Evidence of qualifications is provided by previous employment, references and performance evaluations

Desired Qualifications*

  • Experience with multi-institutional protocols
  • Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) Certification (required within 2 years of DOH)
  • Some IRB/regulatory experience
  • Experience with the University of Michigan’s eResearch system
  • Experience with EPIC (Mi-Chart) Electronic data system
  • Oncology experience
  • Reasonable knowledge of University research policies, procedures and computer systems

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.