Provide effective specimen management, including preparing
kits, preparing shipments, tracking inventory, etc.
Delegate and ensure complete and accurate study data
collection, through patient interactions, survey management,
electronic medical records, etc.
Perform ophthalmic technical procedures (e.g., visual acuity,
tonometry, perimetry, imaging) as required by the study protocol,
and train team members on these procedures, minimizing the need for
outside clinical staff support.
Oversee and maintain subject research charts in adherence to
Good Clinical Practice and sponsor requirements.
Enter study data into OnCore clinical trials management system
and required sponsor platforms, and ensure quality control for data
entered by team members.
Work with the Investigators to ensure the timely review and
reporting of adverse reactions and severe adverse events.
Entering all study subjects visits appropriately to make sure
patient billing is accurate.
Lead and manage relationships with sponsors and contractors to
conduct site initiation visits, monitoring visits, program audits,
etc. (i.e. serve as primary point of contact)
Responsible for implementing accurate device and drug
accountability processes according to sponsor and regulatory
requirements.
Oversees and leads visits with sponsors; including site
initiation visits, interim monitoring visits, audits, and closeout
visits
Coordinate study needs with the Eye Clinic, the Clinical
Research Unit, and Investigational Drug Services (IDS) to execute
study visits according to protocol
Provide guidance to clinic staff regarding ophthalmic technical
procedures (e.g., visual acuity, tonometry, perimetry, imaging) as
required by the study protocol
Responsible for complete and accurate study data collection,
through patient interactions, survey management, electronic medical
records, etc.
Responsible for the maintenance of subject research charts in
adherence to Good Clinical Practice and sponsor requirements.
Maintain accurate subject reimbursement, where applicable.
- Track sponsor payments and reconcile study accounts.
- Ensure accurate billing and documentation of research-related
services.
- Review protocol amendments to ensure budget updates align with
study requirements.
- Support pre- and post-award financial processes as needed.
Data Management (30%)
- Serves as primary contact for the collection and completion of
required study documentation
- Develops and maintains study documentation to ensure
audit-proof compliance
- Abstracts data from the medical record to ensure accurate and
complete documentation
- Manages electronic data capture systems, including but not
limited to data entry, query resolution, and meeting data lock
deadlines
- Demonstrates proficiency with Adverse Event grading, medical
terminology, critical lab values, and other disease-specific
diagnostic criteria
- Oversee proper documentation of clinical procedures and ensure
patient safety and data integrity and accuracy
Coordinate Research Studies for the inter-departmental studies
(5%)
- Coordinate research study procedures for other departments who
require ophthalmology services per protocol
Regulatory (20%)
- Identifies, reviews, and reports adverse events, protocol
deviations, or other unanticipated problems appropriately.
- Independently contributes to study start-up activities, such as
site initiation visits and staff training.
- Independently contributes to the preparation and submission of
regulatory documentation for the clinical study, such as the
Institutional Review Board application, revision, safety reports,
adverse events, modifications, and yearly renewals.
- Independently creates and maintains source documents.
- Ensure compliance with FDA, NIH, and institutional regulations.
Maintain complete and current regulatory binders for all assigned
studies.
- Coordinate audit preparation and response with CTSI and
institutional offices; in conjunction with department’s clinical
research manager
- Provide regulatory guidance and serve as a resource for
research staff to ensure compliance
*This work will be done in cooperation with department clinical
research manager and or assigned regulatory specialists if
applicable to individual studies
Other duties as assigned:
- Attend departmental research meetings and CTSI seminars.
- Support departmental research process improvements and policy
development.
- Collaborate with clinical and administrative staff to improve
workflow efficiency and study outcomes.
- Serve as a resource for regulatory and operational best
practices across the department.
- Mentor junior coordinators in study management and professional
development.
- Assist clinical research manager in the development of study
budgets, along with CTSF
Qualifications
All required qualifications must be documented on application
materials.
All required qualifications must be included in the application
materials
REQUIRED QUALIFICATIONS
- Bachelor’s degree and 4 years of clinical or research
experiences or a combination of related education and work
experience to equal 8 years.
- Relevant and direct experience in clinical research to include
data management and following clinical research Standard Operating
Procedures, the Code of Federal Regulations for clinical trials and
Good Clinical Practice guidelines.
- Computer proficiency and ability to navigate multiple software
applications.
- Detail-oriented with exceptional organizational, planning, and
problem-solving skills
- Ability to work in a complex environment
- Ability to maintain professional demeanor when working with
research participants who may have significant medical
concerns
- Strong verbal and written communication skills in English
- Ability to work independently, as part of a team, and with
changing priorities
PREFERRED QUALIFICATIONS:
● Previous experience in a lead, supervisory, or mentorship role in
clinical research within an academic setting
● Certification (COA/COT) or relevant experience as an Ophthalmic
Technician and/or previous experience with Ophthalmology
specialty
● Experience abstracting clinical data and familiarity with medical
terminology, in both adult and pediatric studies
● Clinical Research Coordinator certification (CCRC or CCRA)
● Experience with electronic health systems, preferably EPIC,
Oncore, and clinical trial data collection platforms
About the Department
The Department of Ophthalmology and Visual Neurosciences and its
success is built upon the innovation and drive of every member of
our team, from faculty to administrators to technicians. Put
simply, all of us are driven to provide the best eye care for our
patients, discover new treatments, and educate the next generation
of eye care professionals.
For more information please visit our website at
https://med.umn.edu/Ophthalmology
.
Pay and Benefits
Pay Range: $ 32.28-$37.00 per hour, we anticipate most
offers will be around the midpoint of this range, depending on
education and experience.
Time Appointment: 100% Appointment (40 hours per week)
Position Type: Civil-Service
Please visit the
Office of Human Resources website for more
information regarding benefit eligibility.
The University offers a comprehensive benefits package that
includes:
- Competitive wages, paid holidays, and generous time off
- Continuous learning opportunities through professional training
and degree-seeking programs supported by the Regents Tuition Benefit Program
- Low-cost medical, dental, pharmacy and disability plans
- Healthcare and dependent care flexible spending accounts
- University HSA contributions
- Employer-paid life insurance
- Employee wellbeing program
- Excellent retirement plans with employer contribution
- Public Service Loan Forgiveness (PSLF)
opportunity
- Financial counseling services
- Employee Assistance Program with eight sessions of counseling
at no cost
- Employee Transit Pass with free or reduced rates in
the Twin Cities metro area
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 jobcentr@umn.edu.
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.
About University of Minnesota
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.
At the University of Minnesota, we are proud to be recognized by
Forbes as a Best Employer for Company Culture (2026), Best Employer
for Women (2023, 2025, 2026), and Best Employer by State
(2022-2026). In 2026, we also received Culture Excellence &
Industry Awards recognition for employee appreciation and work-life
flexibility.
