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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

The Department of Obstetrics and Gynecology is passionate about and dedicated to the improving the reproductive health of women.  We are launching a study to understand the factors that contribute to health disparities in women’s reproductive health with a specific focus on uterine fibroids. The Environment, Leiomyomas, Latinas, and Adipocity Study (ELLAS) seeks to address the significant gap in our knowledge of fibroids in the fastest growing group of women in the United States. We are looking for a talented, bilingual (English/Spanish) and experienced individual that possesses great organizational and communication skills. The ideal candidate will assist in recruitment, data collection, and obtaining informed consent. This person will be a liaison between participants, the study team and the sponsor.  This position will be responsible for screening, recruitment and capturing participant data; data management (collect, record and input hard and electronic study forms, and quality assurance); coordinating study visits/activities; communicating with participants; working with health care providers in recruitment; serving as a resource and contact person for active protocols; communicating and relaying data to entire study team and data entry; reporting weekly on subject enrollment and progress in studies and ensuring compliance with the protocol and adherence to Good Clinical Practice obligations. The candidate will provide logistical support to the study on a daily basis in the field, including travel to the participating clinical sites; travel to sites throughout Michigan will be required. The candidate will work closely with the project manager and PI to meet study objectives.

Responsibilities*

Study Coordination

  • Oversight of the recruitment, enrollment and retention of subjects
  • Develop and implement effective study recruitment strategies
  • Develop study start up materials, including flyers, consent forms, etc
  • Supervise the scheduling and screening of potential of patients
  • Update and maintain IRB
  • Monitor study progress toward goals and modify resources as needed
  • Develop site Standard Operating Procedures (SOPs)
  • Maintain all study essential documents including responsible completion of all case report forms and accurate source documentation
  • Act as a liaison between clinical research team and sponsor, as well as between patient, investigator, project manager and regulatory agencies
  • Oversight and responsible for research billing payment and invoices for studies
  • Work with internal resources and sponsor to facilitate specimen collection

 Quality Control and Compliance

  • Create, update and maintain IRB applications (amendments, ORIOs, AEs)
  • Manage and maintain compliance with regulatory requirements and study protocols
  • Provide oversight of data collection to ensure compliance with protocol and data protection
  • Directly report any issues to the project manager and Principal Investigator and implement necessary actions to reconcile the issue
  • Process and ship specimens ensuring compliance
  • Meet and work with sponsor study monitors
  • Address and respond in a timely manner to sponsor queries, database completion and regulatory issues

 Team Supervision

  • In conjunction with project manager supervise patient recruiters, including monitoring all aspects of daily tasks, attendance and time reporting
  • Train new recruitment staff in all elements of clinical study
  • Assist project manager and PI with evaluations of research staff

 Outreach and Education

  • Coordinate outreach to community clinics and organizations
  • Act as a liaison between PI and out of network sites
  • Facilitate educational events to engage communities
  • Travel to local and international sites to teach study protocols and research principles

 Other duties as assigned by the project manager and PI

Required Qualifications*

  • Bachelor’s Degree is required.
  • At least two years of human subject research experience, preferably in Women's Health
  • At least one-year experience with IRB initial application submissions and amendments.
  • Fluent Conversational Spanish and English Required
  • Knowledge of Good Clinical Practice and ICH regulatory guidelines
  • Proficiency with Microsoft Office programs including PowerPoint and Excel
  • Willingness and ability to travel to nearby counties for community outreach
  • Demonstrated coordination, time management, communication skills and ability to work independently and as a team member
  • Demonstrated ability to build and maintain relationships with research teams including Principal Investigators

Desired Qualifications*

  • Master’s degree is strongly desired
  • Previous experience training staff
  • Previous experience with MiChart, RedCap, and Qualtrics
  • Knowledge of University of Michigan policies and procedures
  • Previous community based experience
  • Previous supervisory experience, preferably in a research setting

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.