This Research Project Manager (RPM) position will be responsible for supporting efforts to create more robust clinical research infrastructure for Alzheimer’s Disease and Related Dementias (ADRDs) science. The RPM will work with a dynamic team of faculty investigators, staff, and learners. He/she will be responsible for the day-to-day coordination of study tasks including recruitment/enrollment activities and facilitation of study-specific administrative and regulatory activities. The goal of this position is to create infrastructure in support of a successful application for an NIA Alzheimer’s Disease Research Center or similar multi-faculty collaborative, extramurally funded initiative.
Major responsibilities of this position, with the percentage of time devoted to each:
Research Project Management (45%):
Act as the primary information resource to University faculty, staff and clinical partners for protocol specific queries, including availability of Center trials, enrollment requirements, specimens needed, etc.;
Interpretation and implementation of study protocols, procedures and definitions for the study teams;
Coordinate the enrollment of eligible participants, manage and coordinate research subject's participation, perform patient evaluations, extract and report quality patient data and samples, and respond to data queries;
Lead the establishment of an ADRD biobank in compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies.
Research Regulatory Management (25%):
Development, submission and maintenance of IRB protocols (new and renewal) on behalf of Center Investigators and staff;
Responsible for interpretation of, application of, and compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols;
Ensure timely and accurate data and regulatory (FDA and IRB) submissions; engage with Investigators and study staff to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of participant research charts.
Community Outreach and Communications (20%)
Timely communication with the IRB, SPA, sponsoring agencies, PI’s, other clinica/service providers, participants, their families, and research team members;
Identify, establish and develop effective mutually beneficial relationships with community partners to promote ADRD science and research participation opportunities.
Other Administrative Duties (10%)
As assigned; attend and participate in regular Center meetings.
All required qualifications must be documented on application materials
BA/BS degree and at least five years of applicable research experience or an advanced degree with at least three years of experience or a combination of related education and work experience to equal nine years
Demonstrated strong communication, written, interpersonal, organizational, analytical, and data management skills
Ability to manage work amidst changing priorities and ambiguous environment, potentially with multiple Principal Investigators (PI’s) across multiple projects
Ability to work independently, make decisions, problem solve, triage and prioritize tasks
Experience in preparing IRB applications and study-related documentation
Demonstrated ability to analyze, design, and optimize complex processes
Experience and demonstrated success in establishing and maintaining effective and collaborative working relationships with stakeholders from a variety of backgrounds, communities, and organizations
Proficient with various technology applications including: MS Office (Word, Excel & PowerPoint), the Google Suite (email, calendars, Drive, Doc’s), Microsoft Teams, Zoom, and various database software
Background in biomedical research, clinical trials, public health, health care delivery, and/or community engagement methods
Experience interacting with People Living With Dementia (PLWD) and their families
Familiarity with the University of Minnesota IRB, Fairview Research Administration, and M Health Fairview hospitals and clinics
Experience with EPIC or other electronic medical records
Familiarity with REDCap
Knowledge of Good Clinical Practices (GCP) and medical terminology
SOCRA / ACRP certification or SOCRA / ACRP-eligible
Internal Number: 340510
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.