Research Professional 4 - LCRU Project Manager
Company: University of Minnesota
Location: Minneapolis
Posted on: January 28, 2023
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Job Description:
Apply for JobJob ID348148
LocationTwin Cities
Job FamilyResearch-Support
Full/Part TimeFull-Time
Regular/TemporaryRegular
Job Code8352P4
Employee ClassCivil Service
Add to Favorite JobsEmail this JobAbout the Job
The purpose of this role is to facilitate the initiation of a new
clinical trial through the start-up process to enrollment. This
person will ensure a timely start-up for new clinical trials, as
well and facilitate changes needed to studies already conducted in
the LCRU. This person would work closely with the whole research
team: research staff, Investigators, IRB, and finance. They will
work closely with the Director to manage the Cardiology research
portfolio. In addition, this position will help develop budgets,
oversee invoicing, provide regular project and portfolio reporting
updates and provide back-up to the IRB specialist. The successful
candidate will be a self-starter with excellent people skills and
the ability to manage multiple priorities and deadlines with
changes as requests come through.
Responsibilities: Study Set-Up & Ongoing Study Management (35%) 1.
Assists investigators by providing strategic and operational
expertise to grant applications, IRB submission, budgets and other
clinical and translational research processes. 2. Serves as a
primary information and training resource for staff and partners
related to the study start-up, OnCore, Florence, e-consent and
other internal required systems. 3. Manages project set-up in
OnCore and facilitates updates, as needed. Works closely with IRB
specialist, finance, and study coordinator to efficiently move a
study through the start-up process. 4. Work with research team and
outside partners to develop pricing and initial budget needs. 5.
Attend start-up meetings for calendar builds and study execution.
6. Attend meetings that relate to the systems for study start up
and management to represent the department. 7. Conducts study
progress reporting, manages enrollment progress reports & portfolio
reporting
Regulatory Maintenance (25%) 1. Work alongside the IRB specialist;
provides back-up as needed with high demand and during absences.
Communicates closely with study team and IRB specialist on triaging
regulatory priorities in terms of study start-up, study updates,
protocol amendments, etc. 2. Facilitates and manages e-consent
set-up and Florence e-regulatory binder processes 3. May assist
with continuing reviews for active studies, update IRB as needed
for AEs, UPIRTSOs, etc. 4. Maintains up-to-date knowledge of HIPAA,
regulatory guidance and institutional requirements (NIH, FDA, UMN
Research Requirements, Fairview Requirements, Health and Human
services) 5. Oversee the maintenance of central regulatory files
and staff credentials. 6. Manages study archival at end of project.
7. Follow Good Clinical Practice
Grant/Budget Preparation & Oversight (30%) 1. May develop or assist
with budget development and obtaining pricing estimates 2. Tracks
and monitor expenses and study budget. 3. Monitors trial budgets
with the assigned coordinator to assure appropriate and adequate
ongoing resourcing. 4. Oversees Material transfer agreements and
Confidentiality Agreements 5. Ensure deadlines, schedules and
budgets are met while keeping in compliance with local regulations
and GCP.
Research Unit Liaison (external sponsors/monitors, MDs, IRB, and
Department) (10%) 1. Meets directly with principal investigator to
facilitate problem solving and redesign of study/project, when
necessary. 2. Attend meetings with Fairview departments on billing
and pricing issues and supply contract 3. Identify and work to
implement resources needed Technical Knowledge and Skills: 1.
Knowledge of principles and practices of project management. 2.
Experience with managing clinical trials. 3. Ability to work with
investigators of all experience levels. 4. Knowledge of
regulations, policies and procedures at the University of Minnesota
in clinical research 5. Skill in the effective use of computer
systems and software 6. Skill in ensuring the accomplishment of
team or work unit goals, objectives and activities. General Skills
and Attributes: 1. Cognitive skills (analysis, decision-making,
Qualifications
All required qualifications must be documented on application
materialsRequired Qualifications:
Benefits
Working at the UniversityAt the University of Minnesota, you'll
find a flexible work environment and supportive colleagues who are
interested in lifelong learning. We prioritize work-life balance,
allowing you to invest in the future of your career and in your
life outside of work.The University also offers a comprehensive
benefits package that includes:
How To Apply
Applications must be submitted online. To be considered for this
position, please click the Apply button and follow the
instructions. You will be given the opportunity to complete an
online application for the position and attach a cover letter and
resume.Additional documents may be attached after application by
accessing your "My Job Applications" page and uploading documents
in the "My Cover Letters and Attachments" section.To request an
accommodation during the application process, please e-mail
employ@umn.edu or call (612) 624-UOHR (8647).
Diversity
The University recognizes and values the importance of diversity
and inclusion in enriching the employment experience of its
employees and in supporting the academic mission. The University is
committed to attracting and retaining employees with varying
identities and backgrounds.The University of Minnesota provides
equal access to and opportunity in its programs, facilities, and
employment without regard to race, color, creed, religion, national
origin, gender, age, marital status, disability, public assistance
status, veteran status, sexual orientation, gender identity, or
gender expression. To learn more about diversity at the U:
http://diversity.umn.edu.
Employment Requirements
Any offer of employment is contingent upon the successful
completion of a background check. Our presumption is that
prospective employees are eligible to work here. Criminal
convictions do not automatically disqualify finalists from
employment.
Please note: All employees at the University of Minnesota are
required to comply with the University's Administrative Policy:
COVID-19 Vaccination and Safety Protocol by either providing proof
of being fully vaccinated on their first day of employment, or
complete a request for an exemption for medical exemption or
religious reasons. To learn more please visit:
https://safe-campus.umn.edu/return-campus/get-the-vax
About the U of M
The University of Minnesota, Twin Cities (UMTC)The University of
Minnesota, Twin Cities (UMTC), is among the largest public research
universities in the country, offering undergraduate, graduate, and
professional students a multitude of opportunities for study and
research. Located at the heart of one of the nation's most vibrant,
diverse metropolitan communities, students on the campuses in
Minneapolis and St. Paul benefit from extensive partnerships with
world-renowned health centers, international corporations,
government agencies, and arts, nonprofit, and public service
organizations.
Keywords: University of Minnesota, Minneapolis , Research Professional 4 - LCRU Project Manager, Executive , Minneapolis, Minnesota
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