Clinical Research Assistant Jobs in Minneapolis, MN

• 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

• 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

The Clinical Research Coordinator (Research Professional 3) provides comprehensive, high-level study management on a variety of research studies within the Department of Ophthalmology and Visual Neurosciences. This role oversees studies across adult and pediatric programs, serving as the primary liaison between investigators, sponsors, regulatory bodies, and clinical teams.

• Independently lead and oversee the team's efforts in subject screening and recruitment, verifying subject eligibility, facilitating subject enrollments, and timely acquisition of research samples, in close collaboration with the Investigators.
• 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.

• 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 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

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  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

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.

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.

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

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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.

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