Sanford Health · 21 hours ago
Clinical Research Coordinator
Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. The Clinical Research Coordinator will organize and coordinate various clinical trials, ensuring compliance with study protocols and facilitating patient enrollment and follow-up. This role requires collaboration with physician investigators and entails a variety of administrative and patient interaction responsibilities.
ChildrenEducationHealth Care
Responsibilities
Organize complex components of various clinical trials, including the coordination of study-required testing and procedures, as well as investigational treatment for a variety of conditions and symptoms
Participate in listing and clarifying questions and concerns with the investigator and sponsor regarding enrollment goals, sponsor expectations and study procedures
Schedule and coordinate pre-study site visits
Monitor enrollment goals and modify recruitment plan as necessary
Maintain patient screening/enrollment logs and appropriately update sponsors, contract research organizations (CROs) and/or senior medical officers (SMOs)
Assure the completion of all screening, eligibility and enrollment procedures
Conduct interviews to assess subject ability and willingness to follow and complete study procedures and visits
Follow randomization procedures per protocol
Schedule subjects for follow-up visits
Review diaries and questionnaires completed by subjects
Ensure appropriate specimen collection, batching and shipping as required
Collect source documents for sponsor or audit review
Assess subject compliance with the test article and follow-up visits
Abstract data from medical records, clinic, consultation and referral notes for preparation of study forms and flow sheets
Review inclusion/exclusion criteria to assure subject eligibility, and review with physician investigator for final sign-off
Review and verify required source documents in subject medical records to confirm study eligibility
Review study protocol, informed consent form and follow-up procedures with potential study subjects
Prepare case report forms for sponsor or audit review
Responsible for insurance pre-authorization for study participation, as applicable by study
Close collaboration with physician investigators required to ensure safe and compliant investigational treatment or intervention and follow-up per the established research protocol
Document and maintain all study-related procedures, processes and events by planning and design of new forms/source document tools to use in protocol implementation
Document protocol deviations and exemptions
Obtain and review original source documents as needed
Record accurate and timely data onto case report forms
Maintain source documentation for all case report entries, as applicable
Key in data for electronic submission, if applicable
Correct and edit case report form entries as appropriate
Resolve data queries
Ensure drug/device accountability by completing appropriate documentations per individual protocols
Schedule and participate in sponsor monitoring visits and audits to ensure compliance with regulatory requirements governing clinical research
Meet with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues
Qualification
Required
Bachelor's degree in biology, microbiology or related field
May consider graduates of an accredited school of practical nursing as a Licensed Practical Nurse (LPN) dependent on facility and department needs
Benefits
Flexibility for things like appointments/kid drop off
Ability to WFH 1x per week after 6 months
Collaborative team approach and supportive management team
Opportunities for continued learning and professional development
Emphasis on employee wellbeing through annual events and team building activities
Company
Sanford Health
Sanford is a healthcare company providing research, education and clinical care.
H1B Sponsorship
Sanford Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (37)
2023 (38)
2022 (51)
2021 (64)
2020 (30)
Funding
Current Stage
Late StageRecent News
2025-11-20
2025-11-01
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