- 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
- 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
- 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
- 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
- Bachelor’s Degree is required with a Master’s degree preferred.
- At least 2 years of human subject research experience, preferably in Women’s Health
- Knowledge of Good Clinical Practice, ICH and FDA regulatory guidelines
- Experience with clinical trial monitors
- Proficiency with Microsoft Office programs including PowerPoint and Excel
- Willingness and ability to travel to nearby counties for community outreach
- Previous experience training staff
- Demonstrated coordination, time management, communication skills and ability to work independently and as a team member
- Master’s degree is strongly desired
- At least one year experience with UofM e-research IRB initial application submissions and amendments.
- Previous experience with MiChart, RedCap, and Qualtrics
- Knowledge of University of Michigan policies and procedures
- Experience with MBECT and billing calendar tracking
- Previous community based experience
- Previous supervisory experience, preferably in a research setting
- Demonstrated ability to build and maintain relationships with research teams including Principal Investigators
- Willingness to travel domestically and internationally for outreach efforts
This position is grant funded with an anticipated end date of January 31, 2022.
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.
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.
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.