Overview
We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our dynamic research team. This role offers an exciting opportunity to contribute to innovative research projects that advance medical knowledge and patient care. The Clinical Research Coordinator (CRC) is a site-based clinical research professional responsible for the day-to-day conduct and coordination of clinical trials under the direction of the Clinical Research Manager (CRM). This role serves as the primary on-site clinical execution role, with ownership of the majority of patient-facing study visits, source documentation, EDC entry and query resolution, protocol adherence at the visit level, day-of-study logistics, sponsor/monitor execution support, and surgical-study coordination as assigned.
The CRC also maintains delegated regulatory and study documentation systems under Clinical Research Manager oversight and may provide limited task direction and workflow support to Research Assistant staff. This position requires strong clinical judgment, advanced organizational ability, and the technical capacity to perform Tier 1–3 research procedures as trained and assigned
Responsibilities
- Serve as the primary owner of day-to-day study execution for assigned protocols
- Coordinate and conduct patient-facing research visits in accordance with study protocols, site workflows, and delegated authority, including primary ownership of approximately 75% or more of study visits overall
- Support and complete the informed consent process per protocol and site workflow, including explaining study participation, answering participant questions within scope, and ensuring required consent documentation is completed accurately
- Complete, maintain, and quality-check source documentation and other required study records
- Own EDC data entry, query resolution, and timely data follow-up for assigned studies
- Support identification, documentation, escalation, and follow-up of adverse events, protocol deviations, and other reportable study issues in accordance with site workflow and investigator oversight
- Manage day-of-visit logistics, troubleshooting, and coordination across patients, providers, research staff, clinic staff, and external study partners
- Maintain regulatory binders, delegated study documentation, and study systems as assigned.
- Serve as the primary site contact for sponsors and monitors for routine study execution matters, including visit preparation, follow-up, and document support
- Coordinate surgical-study logistics and provide research support for surgical protocols as assigned
- Oversee protocol adherence at the visit level and identify operational issues needing escalation or correction
- Support investigator-initiated trial (IIT) source documentation, database creation, and selected development activities as assigned
- Support delegated startup, close-out, regulatory, or finance-adjacent tasks as assigned, without assuming department-level ownership
- Maintain physical study supply readiness, including par-level oversight of study materials such as binders, dividers, electronic blood pressure cuffs, lab kits, and related research supplies, and communicate with the Clinical Research Manager when reorders are needed
- Maintain gift card inventory tracking and reconciliation, where applicable
- Coordinate subject scheduling, visit reminders, enrollment tracking, retention follow-up, and dropout documentation as needed for assigned studies
- Communicate with laboratories, sponsors, monitors, investigators, and internal teams regarding study logistics, required follow-up, and study execution needs
- Collect, prepare, process, and ship study samples in accordance with protocol requirements and assigned technical scope
- Perform protocol-required clinical and technical procedures within training and certification scope, including Tier 1, Tier 2, and Tier 3 (see below) tasks as assigned
- Provide overlapping visit coverage and advanced execution support when multiple studies or high-volume clinic days require it
- Provide limited day-to-day collaboration with Research Assistant staff for assigned study tasks, clinic flow, and visit support activities
- Assist with onboarding and protocol-specific workflow training for Research Assistants and/or other CRCs as assigned
- Support tasks such as pre-screening, exploratory EMR data extraction, reminder calls, and related operational coverage
- Maintain confidentiality of patient, sponsor, protocol, and organizational information at all times
- Adapt to changing schedules, protocol requirements, study priorities, and operational demands with a solutions-focused approach
- Travel locally between clinic sites, surgery centers, and other work-related locations as needed
- May expand cross-study coverage capacity to support high-volume clinic days, overlapping visits, weekend/surgical-study needs, and other operational priorities
- Other duties as assigned
DEVELOPMENTAL OPPORTUNITIES
- Expected to have or quickly develop proficiency in Tier 1, Tier 2, and Tier 3 research skills as required by assigned studies, site needs, and training plan
- Tier 1 tasks as trained and assigned, including lab shipment support, urine sample collection, and pregnancy testing
- Tier 2 tasks as trained, certified, and assigned, including certified visual acuity, certified OCT, and certified fundus photography
- Tier 3 tasks as trained, certified, and assigned, including blood draws/phlebotomy, fluorescein angiography, lab sample processing, and other advanced protocol-specific imaging or testing
- May participate in delegated tasks related to investigator-initiated trial (IIT) development, including source documentation support, database development support, feasibility-related support tasks, and other assigned operational activities under Clinical Research Manager oversight
- May assist with onboarding, workflow support, and protocol-specific training for Research Assistant staff and newer CRC team members as delegated
Knowledge, Skills, and Abilities
- Technology skills: Microsoft Office, Electronic Data Capture (EDC) systems, EMR systems, and study-related sponsor portals/databases
- Working knowledge of Good Clinical Practice (GCP), informed consent workflow, protocol compliance, source documentation standards, and adverse event/protocol deviation reporting
- Ability to independently coordinate and conduct patient-facing research visits in accordance with protocol requirements and site workflow
- Ability to manage study flow, visit logistics, source documentation, EDC entry, query resolution, and study follow-up for assigned protocols
- Ability to prioritize and manage multiple studies, competing deadlines, and changing operational demands with limited supervision
- Ability to identify protocol, workflow, or patient-care issues and escalate concerns appropriately to the Clinical Research Manager, Principal Investigator, or Sub-Investigator
- Ability to support sponsor/monitor interactions for routine study execution matters, including visit preparation, follow-up, and document support
- Ability to maintain regulatory binders and delegated study documentation under Clinical Research Manager oversight
- Ability to provide limited day-to-day task direction, workflow guidance, and protocol-specific support to Research Assistant staff without formal supervisory authority
- Strong working knowledge of ophthalmic clinical workflows, research visit coordination, and study-specific clinical testing requirements
- Strong attention to detail and accuracy in documentation, data entry, reconciliation, and protocol adherence
- Active Listening: Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate
Join our team to advance groundbreaking medical research through meticulous coordination and innovative laboratory practices!
Pay: $24.00 - $36.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible schedule
- Free parking
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
Application Question(s):
- What salary range are you looking for in your next position?
Experience:
- Clinical research: 2 years (Preferred)
Ability to Commute:
- Minneapolis, MN 55433 (Preferred)
Work Location: In person
