Clinical Research Coordinator

Sanford Health • Sioux Falls, SD

2d

About The Position

Sanford Health is seeking a Clinical Research Coordinator to organize and coordinate clinical trials across a variety of conditions and symptoms. The role includes coordinating study-required testing, procedures, and investigational treatment; supporting recruitment and enrollment; and educating patients, physicians, nurses, and other personnel about the research process. The coordinator works closely with physician investigators and sponsors to carry out research safely and in accordance with study protocols and regulatory requirements.

The position involves managing participant screening, eligibility, enrollment, visits, follow-up, study documentation, data entry, and investigational drug or device accountability. The coordinator also supports sponsor monitoring visits and audits. Occasional local travel between sites and student supervision may be required. The position is scheduled for 40 hours per week on 8-hour day shifts.

Requirements

• Bachelor's degree in biology, microbiology, or a related field.
• Minimum of three years of clinical or clinical research experience, or six to eight years of relevant work experience.
• If employed as an LPN, an unencumbered LPN license with a state nursing board and/or multi-state licensure privileges.
• Obtain and maintain required department-specific competencies and certifications.
• Enthusiasm for learning.

Nice To Haves

• Graduation from an accredited practical nursing program as an LPN may be considered, depending on facility and department needs.

Responsibilities

• Organize clinical trial components, including study-required testing, procedures, and investigational treatment.
• Clarify enrollment goals, sponsor expectations, and study procedures with investigators and sponsors.
• Schedule and coordinate pre-study site visits; monitor enrollment goals and adjust recruitment plans as needed.
• Maintain screening and enrollment logs and provide updates to sponsors, CROs, and/or SMOs.
• Complete screening, eligibility, enrollment, and randomization procedures according to protocol.
• Interview prospective subjects to assess their willingness and ability to complete study procedures and visits.
• Schedule follow-up visits and review participant diaries and questionnaires.
• Coordinate specimen collection, batching, and shipping as required.
• Collect and review source documents for sponsor or audit review; abstract medical record information for study forms and flow sheets.
• Review eligibility criteria and source documents, and coordinate physician investigator sign-off on eligibility.
• Explain study protocols, informed consent forms, and follow-up procedures to potential participants.
• Prepare case report forms and enter, correct, and verify study data; resolve data queries and maintain supporting source documentation.
• Arrange insurance pre-authorization for study participation when applicable.
• Collaborate with physician investigators to ensure safe, compliant investigational treatment or intervention and follow-up.
• Create or plan forms and source-document tools for protocol implementation; document study procedures, events, deviations, and exemptions.
• Maintain drug and device accountability documentation according to individual protocols.
• Schedule and participate in sponsor monitoring visits and audits, discussing case report forms, queries, and protocol-related issues.
• Educate patients, physicians, nurses, and other personnel about the research process.
• Provide student supervision as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level