Clinical Research Coordinator

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.

The CRC works closely with the Principal Investigator (PI), sub-investigators, Clinical Operations Manager, and cross-functional research teams to ensure study integrity, subject safety, and high-quality data collection.

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.

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