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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 looking for a study coordinator for a studies within the onWHARD (Women’s Health and Reproductive Disparities) group to understand the factors that contribute to disparities in women’s reproductive health. These studies seek to address the significant gap in our knowledge of fibroids and other Women’s Health and Reproductive issues. We are looking for a talented and experienced research coordinator who possesses great organizational and communication skills.
 
The ideal candidate will support with recruitment, data collection, obtaining informed consent, along with coordinating with recruiting clinics and sites.
 
He/She will support the site in communicating with participants; working with health care providers in recruitment; serving as a resource and contact person for active protocols; reporting weekly on subject enrollment and progress in studies. The candidate will work closely with the team Operations Manager and PI to meet study objectives.

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*

Study Coordination:
  • Oversight of the recruitment, enrollment and retention of subjects
  • Develop study start up materials, including flyers, consent forms, brochures, data collection forms, etc.
  • Order or support ordering of inventory/lab materials needed for study conduct
  • Monitor study progress toward goals and modify resources as needed; support with Co-I meetings and conference call agenda and minutes
  • Coordinate and support with manuscript writing discussions and data analysis
  • Develop and Maintain Standard Operating Procedures (SOPs)
  • Maintain all study essential documents including responsible completion of all case report forms and accurate source documentation
  • Engage professionally with outside stakeholders and vendors to support study needs
  • Oversight and responsible for research billing and invoices for studies
  • Work with internal resources and sponsor to facilitate specimen collection, transport and storage
 
Data Collection and Database Management:
  • Coordinator will develop forms in REDCap to capture data and support the enrollment site with coordinating study visits/activities.
  • Provide oversight of data collection; monitor and continuously ensure data collection forms meet study data collection needs.
 
Quality Control and Compliance:
  • Create, update and maintain IRB applications (amendments, ORIOs, AEs)
  • Manage the protocol and operations document versions for required changes
  • Maintain compliance; Identify potential issues; directly report issues and implement necessary actions to resolve issues
  • Meet and work with sponsor study monitors
  • Address queries, data needs, and regulatory issues
 
Team Supervision:
  • In conjunction with Operations Manager supervise the study team of patient recruiters
  • Assist with monitoring of daily tasks - scheduling, attendance and time reporting
  • Identify and recommend staffing needs; Train new staff
 
Outreach and Education:
  • Act as a liaison between PI and network sites
  • Support onWHARD team with facilitating educational events to engage communities
  • Travel to local sites when needed
  • Other duties as assigned

Required Qualifications*

  • Bachelor’s Degree is required
  • Two – four years of coordinating human subjects research, with interest in Women's Health
  • At least 1-2-year experience with completing full IRB initial application submissions and amendments is required
  • Experience with Investigator Initiated, Sponsored, and Co-Op group research
  • IT Proficiency with Microsoft Office programs including Word, PowerPoint and Excel required
  • Willingness and ability to travel regularly to nearby counties for study visits
  • Demonstrated effective study coordination, time management, self-starter
  • Excellent communication skills
  • Knowledge of FDA regulations; Good Clinical Practice and ICH guidelines
  • Self-directed; ability to work independently and as a team member

Desired Qualifications*

  • Master’s degree is strongly desired; ACRP or SoCRA Certification Desired
  • Previous experience training research staff
  • Previous experience with MiChart, RedCap, Canva, Qualtrics, and other applications
  • Knowledge of University of Michigan policies and procedures
  • Previous community based experience or strong interest
  • Previous Women’s Health experience or strong interest
  • Previous supervisory experience, preferably in a research setting
  • Phlebotomy certified

Additional Information

This is a grant funded position.

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.