The Pediatric Nephrology Clinical Research program is a collaborative, collegial and fast paced program that enjoys the opportunity to partner with many intramural and extramural researchers. The Research Program includes clinical trials, longitudinal cohorts, health services, and translational research with funding from a variety of sponsors including NIH, industry, and others. The patient–centered research program focuses on acute and chronic kidney diseases with an emphasis on nephrotic syndrome.
The Research Area Specialist is responsible for managing his/her assigned projects and serving as a key team member. The research team includes physicians, biostatisticians, a program manager, project managers, study coordinators, data analyst, data manager, and administrative assistant. Research trainees are added to the team on occasion.
The Research Area Specialist is expected to understand and support the conduct of research within all federal, state and local regulatory requirements. Candidate participates in all regulatory and oversite aspects of research projects and proposals. Assignments may include start up and monitoring tasks for both single and multi-center studies. Tasks can be expected to include but not limited to protocol and manual of operations drafting, regulatory and review board submissions and communication, communication with project-specific team members, and training of internal and external research personnel. Additional patient facing activities including conduct of patient consent for research and conduct of study visits are also expected.
Assist in the development and review of all phases of study design with attention to the regulatory and review board perspective, including the development of grants, protocols, manual of operations, case report forms, and study database
Development of informed consents/assents both for local use and as templates
Manage local and central IRB applications from initial submission through study close out
Conduct protocol related training for study coordinators and co-investigators internally and at other institutions as needed
Monitor study activities to ensure compliance with protocols, quality control, data completion, and submission of study related documentation to the appropriate reporting agencies
Maintain knowledge of federal, state and local regulatory requirements for the responsible conduct of research; assist with SOP development and training
Perform study coordination activities for assigned projects including recruitment and consent of study participants; collect, process, label and store biospecimens including blood, urine, and kidney biopsy samples; data collection and data entry into electronic databases; study team communication
Assist with budget review and negotiations for grant and industry budget development
Communicate effectively across diverse project teams
Travel up to 10% of the time may be required to conduct site assessment, monitoring, and/or attend project team meetings.
Bachelor’s degree in biological, social, or medical sciences, or equivalent combination of education and relevant experience.
5 years of clinical research experience
Experience with human subjects research and working knowledge of FDA, ICH-GCP, and other regulatory compliance guidance
Pre-award administrative experience including industry trial start up
Experience conducting or monitoring clinical trials
Demonstrated excellence in interpersonal and communications skills, both oral and written.
Thorough knowledge of personal computers and Microsoft applications.
Ability to prioritize, pay close attention to detail, follow-through with tasks, and work as part of a team with medical professionals
Demonstrated ability to observe and maintain data confidentiality.
Excellent attendance and strong work ethic.
Knowledge of medical terminology.
Regulatory or project management or clinical monitoring experience highly preferred
SoCRA Certified Clinical Research Professional (CCRP), Association of Clinical Research Professionals (ACRP) Certified Clinical Research Associate (CCRA) or other related certification is highly preferred
Experience with multi-site clinical trial management
Knowledge of human biospecimen collection and storage methodology and processes.Familiarity with eResearch applications
Familiarity with eResearch applications
Administrative supervision is received from the Division Administrator. Functional supervision is received from Director of the Pediatric Nephrology Research Program. Staff members in this classification are expected to work independently and regularly exercise judgment in setting priorities, resolving operational problems and the application of policies, procedures and methods, while maintaining the strictest of confidentiality at all times. A very strong work ethic is required with appreciation for the importance of complete and accurate research data and specimen handling
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 168879
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.