Clinical Research Coordinator

Job Details:

Job Location:

Lincoln, NE - Lincoln, NE 68516, Position Type:
Full Time, Education Level: 4 Year Degree, Job Category:
Research, Be Well Clinical Studies is seeking a detail-oriented and patient-centered Clinical Research Coordinator (CRC) to manage and execute clinical research studies at our Lincoln site. This role serves as a primary operational lead on assigned protocols, ensuring studies are conducted in accordance with sponsor requirements, FDA regulations, and Good Clinical Practice (GCP) standards.

• Manage day-to-day study operations in accordance with protocol, GCP, and regulatory requirements
• Maintain Investigator Site Files (ISF) and study documentation in electronic systems (CRIO, sponsor portals)
• Ensure protocol adherence and support audit/monitoring readiness

• Conduct and document the informed consent process
• Perform subject visit coordination including scheduling, follow-ups, and visit flow management
• Collect medical history, medication history, and demographic data
• Monitor subjects for Adverse Events (AEs) and Serious Adverse Events (SAEs) and ensure timely reporting

• Collect vital signs, ECGs, height/weight, and clinical assessments as delegated
• Support laboratory specimen collection, processing, packaging, and shipment
• Monitor storage conditions of study supplies and samples

• Complete and maintain source documentation in CRIO (eSource)
• Enter and reconcile data in Electronic Data Capture (EDC) systems
• Respond to data queries and support data accuracy initiatives

• Assist with IP accountability, storage monitoring, and documentation
• Support IP administration and subject education when applicable

• Utilize internal platforms including CRIO, Smart Sheets, Ninety, Outlook, and sponsor portals
• Coordinate with regulatory, QC/EDC, and recruitment teams
• Participate in Site Initiation Visits (SIVs), monitoring visits, and investigator meetings

This position is primarily clinical and patient-facing, with responsibilities requiring attention to detail, regulatory compliance, and collaboration in a fast-paced research environment.

• Minimum 2 years of clinical research experience (CRC or equivalent role)
• Strong understanding of Good Clinical Practice (GCP)
• Ability to manage multiple protocols and deadlines
• Excellent organizational and communication skills

• Bachelor’s degree in health sciences, biology, or related field
• Experience with EDC systems and electronic source platforms
• Experience in multi-study site environments