Clinical Research Coordinator -- Multi-Protocol Trials Lead

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

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