Clinical Research Coordinator

Be Well Clinical Studies•Lincoln, NE

20d•Onsite

About The Position

Be Well Clinical Studies is seeking a detail-oriented and patient-centered Clinical Research Coordinator to manage and execute clinical research studies at its Lincoln site. The role serves as the primary operational lead on assigned protocols, ensuring studies comply with sponsor requirements, FDA regulations, and Good Clinical Practice (GCP) standards. The coordinator works closely with the Principal Investigator, sub-investigators, Clinical Operations Manager, and cross-functional research teams to protect study integrity and subject safety and to support high-quality data collection. The position is primarily clinical and patient-facing, involving study operations, participant care, clinical procedures, data management, investigational product support as delegated, and coordination with internal teams and sponsors. It requires attention to detail, regulatory compliance, and collaboration in a fast-paced research environment.

Requirements

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

Nice To Haves

Bachelor’s degree in health sciences, biology, or a related field.
Experience with Electronic Data Capture (EDC) systems and electronic source platforms.
Experience in multi-study site environments.

Responsibilities

Manage day-to-day study operations in accordance with the protocol, GCP, and regulatory requirements.
Maintain Investigator Site Files and study documentation in electronic systems, including CRIO and sponsor portals.
Ensure protocol adherence and support audit and monitoring readiness.
Conduct and document the informed consent process.
Coordinate subject visits, including scheduling, follow-ups, and visit flow management.
Collect medical history, medication history, and demographic data.
Monitor subjects for Adverse Events and Serious Adverse Events and ensure timely reporting.
Collect vital signs, ECGs, height and 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 systems.
Respond to data queries and support data accuracy initiatives.
Assist with investigational product accountability, storage monitoring, and documentation as delegated.
Support investigational product administration and subject education when applicable.
Use internal platforms including CRIO, SmartSheets, Ninety, Outlook, and sponsor portals.
Coordinate with regulatory, QC/EDC, and recruitment teams.
Participate in Site Initiation Visits, monitoring visits, and investigator meetings.