Clinical Trial Navigator II

Javara•Fayetteville, GA

1d•Onsite

About The Position

Javara is an integrated research organization (IRO) that advances value by integrating clinical research within the healthcare ecosystem. Javara brings better outcomes for patient centered care, better economic results, improved access to cutting edge therapies and a more predictable research delivery model to the biopharmaceutical sector. This role operates as the lead Clinical Trial Navigator for multiple clinical studies, responsible for owning the enrollment plan and strategies to achieve and exceed expectations. The role may also serve as a lead CTN across Javara for a single study, providing support and guidance to other assigned CTNs. The position ensures scientific integrity of data, maintains accurate records, and adheres to all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and regulatory requirements. The Clinical Trial Navigator also educates the research team and healthcare staff on study procedures, coordinates patient visits, and performs clinical and laboratory skills.

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

Seek to improve the patient’s experience, never compromising on safety.
Provide excellent customer service to patients and participants, healthcare partner and practice stat investigators, sponsors, and vendors.
Operate as the lead Clinical Trial Navigator for multiple clinical studies, dependent upon site-specific study needs such as study complexity and enrollment goal volume, by owning the enrollment plan and strategies to achieve and exceed expectations. May 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.