Pediatric Surgery is seeking an extremely skilled individual to provide leadership and support for the clinical research initiatives of the Pediatric Surgery Section.
- Assist in the development, planning, and implementation of the pediatric surgery clinical research projects
- Report to principle investigators, and facilitate regular clinical research meetings
- Track study enrollment and report weekly progress to investigators
- Ensure NIH funded studies are in clinicaltrials.gov
- IRB submissions and knowledge of IRB expectations
- Manage the clinical IRB portfolio for pediatric surgery
- Data use agreements & contracts
- Maintain protocol documentation for each study
- Oversee study recruitment and enrollment, including required enrollment reporting
- Manage projects with clinical research fellows
- Work with data managers/analyst to ensure data quality where appropriate
- Create and maintain study databases; perform data queries
- Quality assurance of research protocols
- Work with department administrators on budgets
- Liaison with recruitment sites administrators to ensure stability of research recruitment
- Work with collaborating sites to secure appropriate contracts, data use agreements, training, data and file access, and other regulatory requirements
- Obtain appropriate certificates (COC) where appropriate
- Train and hire extra staff when appropriate; develop training manuals
- A Bachelor’s Degree in clinical research or a related field (public health, epidemiology, social work)
- Minimum of 5 years of experience in clinical research
- NIH study experience preferred
- Excellent communication and leadership skills
- Ability to work accurately
- Excellent interpersonal skills and a strict attention to detail
- Considerable professional experience including supervisory experience
- Demonstrate understanding of principles of scientific method and the ability to apply those principles in carrying out projects
- Strong organizational skills
- Familiarity with regulatory requirements for clinical research
- Strong Knowledge in IRB guidelines and regulations.
- Outstanding organizational skills.
- Master’s or Doctoral Degree preferred.
Monday - Friday 8-4:30pm
This position may be filled using an FLSA exempt or non-exempt designation.
University of Michigan Health System 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.
The University of Michigan Health System 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.The University of Michigan is an equal opportunity/affirmative action employer.