Senior Clinical Trial Navigator

Job Description :

As a Senior Clinical Trial Navigator with Javara, you will be responsible for the coordination and administration of clinical trials and report to the Manager of Site Operations and the Principal Investigator or designee. You will be a critical member of our organization and contribute to patient enrollment efforts within a variety of clinical trials. You will contribute to our continuous improvement through providing creative solutions and approaches to promote study success, exceptional participant experiences, and the integration of clinical research with our healthcare partners. With a guiding principle of research participant safety, you will implement and coordinate research study procedures for the successful management of clinical trials.

Essential 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 with increased enrollment goals and complexity as determined by site specific needs 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 and offering support or guidance to clinical operations team members as appropriate.
• Support enrollment goals by contributing to patient retention strategies and building relationships within local communities.
• Develop 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.
• Identify and provide solutions for opportunities in study protocols to improve overall study experience for patients, investigators, healthcare partners, and other stakeholders.
• 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.
• 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, EKGs, and collecting, processing, and shipping bodily samples.
• Demonstrates commitment to continuous improvement that supports site success.
• Demonstrate our Core Values such as fostering teamwork and collaboration and cultivating relationships with healthcare system representatives.
• Additional tasks as assigned.

Qualifications :

Work Environment :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Physical Demands :

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Travel : This position may require up to 30% travel regionally but may occasionally include travel to other regions or Javara headquarters in Winston-Salem, NC.

Pre-Employment Screening : Drug screen and background check required.

This job description covers the most essential functions of this position and is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee in this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.

Equal Employment Opportunity Statement : Javara provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.