Clinical Research Coordinator

Be Well Clinical Studies; Lincoln (NE); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Be Well Clinical Studies in Lincoln, NE is seeking a detail-oriented Clinical Research Coordinator (CRC) to lead study operations, ensure GCP compliance, and manage data across electronic systems. The role emphasizes regulatory adherence, participant safety, and collaboration with regulatory, QC/EDC, and recruitment teams.

The CRC will conduct informed consent, coordinate visits, collect histories, and monitor adverse events, while maintaining study files and supporting IP management in a

Formación

• Minimum 2 years of clinical research experience (CRC or equivalent).
• 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.

Responsabilidades

• Manage day-to-day study operations per protocol and GCP.
• Maintain ISF and study documentation in electronic systems.
• Ensure protocol adherence and audit readiness.
• Conduct informed consent process.
• Coordinate subject visits and follow-ups.
• Collect medical history and demographic data.
• Monitor AEs/SAEs and report timely.
• Collect vital signs, ECGs, and other assessments.
• Support laboratory specimen collection and shipping.
• Monitor storage of study supplies.
• Enter and reconcile data in EDC systems.
• Respond to data queries and data quality initiatives.
• Assist IP accountability and education.
• Coordinate with regulatory, QC/EDC, recruitment teams.
• Participate in Site Initiation Visits (SIVs) and monitoring visits.

Conocimientos

Clinical research

GCP knowledge

Regulatory compliance

Communication

Organizational skills

Educación

Bachelor's degree in health sciences

Herramientas

CRIO

EDC systems

Ninety

Descripción del empleo

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.

Key Responsibilities

Study Coordination & Compliance

• 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

Participant Care & Safety

• 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

Clinical Procedures

• 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

Data Management

• 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

Investigational Product (IP) Management (as delegated)

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

Systems & Collaboration

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

Work Environment

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

Qualifications: Required:

• 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

Preferred:

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