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Job Summary

The Division of Pediatric Endocrinology is seeking a 15 hour/week Clinical Subjects Research Assistant for the Type 1 Diabetes Pathway to Prevention (TrialNet) Study. This study, which is sponsored by the National Institutes of Health, JDRF, and the American Diabetes Association, is dedicated to the study, prevention, and early treatment of type 1 diabetes. The Clinical Subjects Research Assistant will work under the supervision of the study investigators to fully implement the study protocol.

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.

Responsibilities*

  • Work as a member of a multidisciplinary team to successfully implement the TrialNet protocols
  • Screen and recruit eligible patients for the TrialNet study.  Strategies will include, but are not limited to, medical record review {MiChart, Best Practice Advisories, and external health records), established research registries {eg., umhealthresearch.org, diabetes research registry), outreach to patient and professional groups and other health care providers, coordination and presentation at public recruitment events (e.g., diabetes walks, health fairs), and through printed, web-based and multi-media advertising, and direct mailing campaigns
  • Maintain record of recruitment activities using various secure electronic and file systems, including contacts with candidates, disposition of candidates, outcomes of various recruitment strategies, and status of recruitment efforts. Submit regular reports to the study team of recruitment efforts
  • Assure that study candidates meet eligibility criteria through prescreening activities; e.g., medical record review, and through contact with subjects including telephone screening, face-to-face encounters, e-mail etc.
  • Read and fully understand the Trial Net study protocol and study inclusion, exclusion criteria
  • Obtain and document written informed consent from study participants
  • Develop and maintain patient study schedules according to study guidelines and visit windows
  • Facilitate subject preparation for study visits; e.g., review visit preparation with subjects, reminder calls and appointment letters
  • Ensure appropriate resources (space, research supplies) are available for subject visits. This will include securing visit space in Pediatric clinics, Michigan Clinical Research Unit (MCRU), Canton Health Center, Kellogg Eye Center, or at the Dominos Farms Diabetes Institute.
  • Prepare materials for subject visits, including laboratory collection kits, source documents and Case Report Forms (CRF) as well as required equipment
  • Monitor and maintain inventory of study materials and supplies.
  • Direct interaction with clinical subjects including obtaining biological samples, physical examination data (e.g., blood pressures, waist and hip measurements). Participate in subject visits at request of clinical research staff; may include performing study-specific physical and cognitive test measures.
  • Travel to central study training and monitoring meetings may be required
  • Evening and weekend hours may be required
  • Travel to UM health care centers and other regional health care centers for recruitment purposes may be required

Training will be provided on the following duties:

  • Process, inventory, and ship biological samples to central laboratories
  • Maintain study source documentation and database of TrialNet study participants. This will include tracking and documenting study visits, study visit laboratory and clinical findings, and adverse events. Electronic record systems will be used to record and track subject encounters at outreach clinics
  • Prepare or assist the study investigators/managers in preparation of regulatory submissions, including reporting of amendments, adverse events, and reporting the same to TrialNet data coordinating center and other regulatory bodies as required

Required Qualifications*

  • Prior experience working and interacting with patients in a clinical or clinical research setting within the University of Michigan
  • Prior experience and record of success recruiting subjects for clinical studies
  • Current PEERRS, RCR, and HIPPA certification.  If not current, candidate will be required to take and pass all required modules
  • Trained in phlebotomy/venipuncture
  • Computer proficiency in Microsoft applications including Word, Access, Excel, and Power Point
  • Highly motivated, organized, autonomous person with excellent multi-tasking ability and record- keeping skills
  • Must have a strong attention to detail
  • Professional demeanor and good interpersonal skills
  • Ability to work and communicate with a multidisciplinary team of physicians, scientists, nurses and medical assistants in an outpatient/inpatient clinical setting
  • A working knowledge of medical terminology and assessment of laboratory values

Desired Qualifications*

  • Background in life/health science, LPN/RN licensure, MA certification , or certification from an accredited health care program, or documented experience in direct patient care in a health care or health research setting
  • Prior work experience in diabetes care setting
  • Experience in completing electronic case report forms

Work Schedule

Flexibility of work hours during the work week; some weekends may be necessary as dictated by patient recruitment needs.

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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening 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.