The University of Michigan’s Division of Nephrology is looking for a clinical research project manager (CRPM). This position has the oversight for clinical project(s) and responsibility for ensuring project completion within specifications. The CRPM assists with project development, establishes operational objectives and assignments; defines and manages project resource needs, timelines and budgets; reporting; and analyzes, compares and evaluates courses of action.
Note: This position is located in the State of Arizona.
- Identifies resources and budgets needed to support the project. Facilitates and coordinates communication, schedules, timelines and activities among the various stakeholders. Will assist with database development, and be responsible for database entry/management.
Project Initiation, Oversight, & Reporting:
- Manage the day-to-day operations of the various components related to the study conduct.
- Reviews the project guidelines and requirements.
- Assists with designing source documents, recruitment materials, and other relevant study documents for projects.
- Ensures that regulatory requirements are in place prior to project initiation (IRB approvals, HIPAA, FDA, ICH, standard operating procedures, billing calendars, study budgets, patient consents, execution of study protocol, clinicaltrials.gov study registration, advertising and promotion of project, study close-out and record retention, etc.).
- Ensures that all mandates to protect vulnerable populations are rigorously implemented.
- Manages complex biological sample procurement protocols.
- Attends investigator meetings as part of the study team for project initiation.
- Ensures that key personnel and collaborators meet training requirements in accordance to sponsor, federal and other regulatory guidelines.
- Oversees audits, case report, study visits, data safety monitoring compliance and federal reporting where required.
- Oversees the management of space and equipment.
- Participates in recruitment strategic planning meetings.
- Manages reporting of patient adverse events and medical condition changes.
- Provide statistical support for project results and reporting.
- Oversees subject incentives and required documentation.
- Reviews study budgets, enrollment updates, and timelines in a consistent and continuous manner.
- Assists with dispute resolutions.
- Liaison to IRB staff, other School of Medicine and Public Health department personnel at U Michigan and collaborating institutions regarding clinical research activities.
- Provides guidance, training, and mentorship to collaborating study personnel.
- Oversees the development and implementation of administrative procedures and assignments.
- Recommends strategic direction and provides leadership in short and long-range objectives.
Experience working with vulnerable populations, exhibiting a high degree of cultural sensitivity. Experience providing direct patient care. Candidates with previous experience with clinical research projects are given priority. Proficiency in Microsoft Word, Excel, and Power Point. Confident and highly motivated with excellent multi-tasking ability and record keeping skills. Professional demeanor and excellent interpersonal, communication and writing skills. Proven ability to work independently with minimal supervision. Ability to work with diverse teams of people in a collaborative environment. Ability to problem solve and establish timelines and priorities. Excellent organizational skills with meticulous attention to details. Excellent attendance record.
Bachelor’s degree preferred with at least 2-3 years working in clinical research. Previous experience in Clinical Research Design and Clinical Care provision. Previous experience working with Native American populations. ACRP or SOCRA certified or willingness to become certified. Working knowledge of medical terminology and the ability to sustain a high level of organization while supporting numerous aspects and components of a large, multidisciplinary project.
This position will be located in the State of Arizona.
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.