Clinical Trial Navigator II

Javara•Fayetteville, NC

2d•Onsite

About The Position

This role is responsible for improving the patient's experience in clinical trials while ensuring safety and providing excellent customer service. The Clinical Trial Navigator (CTN) will operate as the lead for multiple clinical studies, owning the enrollment plan and strategies to achieve enrollment goals. They may also serve as a lead CTN across the organization for a single study, providing guidance to other CTNs. The position involves identifying and screening potential participants, contributing to patient retention strategies, and engaging with local communities. Ensuring the scientific integrity of data, accurate record-keeping, and timely query resolution are crucial. The CTN must maintain up-to-date study documentation, report adverse events, and adhere to all SOPs, GCPs, and regulatory requirements. This role also includes conducting and documenting the informed consent process, educating the research team and healthcare staff, coordinating patient visits, and performing clinical and laboratory skills such as obtaining vitals, EKGs, and phlebotomy. Continuous improvement, effective communication, and fostering teamwork are also key aspects of this position.

Requirements

Associates or Bachelor’s Degree in related field or equivalent industry experience.
2+ years of experience in clinical research that includes hands-on application of clinical functions such as obtaining vitals, EKGs, and phlebotomy.

Responsibilities

Operate as the lead Clinical Trial Navigator for multiple clinical studies, owning the enrollment plan and strategies to achieve and exceed expectations.
Serve as a lead CTN across Javara for a single study, providing support and guidance to other assigned CTNs.
Execute the enrollment plan of assigned studies to meet requirement goals by identifying and contacting potential participants and screening to enroll into suitable studies.
Support enrollment goals by contributing to patient retention strategies and building relationships within local communities.
Participate in developing creative approaches to patient recruitment and retention strategies, including participating in community engagement.
Ensure scientific integrity of data and record source data appropriately and accurately inclusive of patient visit data within source, CTMS, electronic reporting systems, completing the sponsor’s case report form, and timely query resolution.
Ensure study documentation is up to date and audit ready, including reporting of adverse events and deviations with investigational products.
Adhere to all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, proper PPE usage and other regulatory authority requirements.
Conduct and document the informed consent process.
Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements.
Coordinate and schedule patient visits and conduct visits per protocols.
Support continuous improvement by assisting in implementing updated processes or procedures intended to improve the experience of internal and external stakeholders.
Appropriately communicate and escalate to support responsiveness and resolution with our healthcare partners and other external stakeholders.
Perform clinical and laboratory skills such as therapeutic area specifics, obtaining vitals, phlebotomy, EKGs, and collecting, processing, and shipping bodily samples.
Demonstrate thoughtfulness on the continuous impact of your role on study and site success.
Demonstrate our Core Values such as fostering teamwork and collaboration and cultivating relationships with healthcare system representatives.
Additional tasks as assigned.