Clinical Trial Navigator II

Javara; Winston-Salem (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Javara in Winston-Salem, NC seeks an experienced Clinical Trial Navigator to lead enrollment plans and strategies for multiple studies. You will work with healthcare partners, sponsors and vendors to optimize patient recruitment while maintaining safety and data integrity.

The role emphasizes executing enrollment plans, screening participants, and ensuring regulatory compliance. You will collaborate with site teams, support patient retention, and contribute to study documentation and quality

Qualifications

• Hands-on clinical research experience including vitals, EKGs and phlebotomy.
• Able to coordinate patient visits and enrollment activities.
• Knowledge of regulatory requirements (GCP/SOPs) and safety protocols.

Responsibilities

• Lead enrollment planning and strategies to achieve enrollment goals.
• Provide excellent customer service to patients, healthcare partners, sponsors, and vendors.
• Execute enrollment plans, identify potential participants and screen for eligibility.
• Ensure data integrity and proper documentation across source data, CTMS and CRFs.
• Adhere to SOPs, GCPs, OSHA, PPE, and regulatory requirements.
• Coordinate and schedule patient visits; obtain informed consent; communicate with stakeholders.

Skills

Clinical research coordination

Phlebotomy

EKG

Vital signs collection

Customer service

Education

Associate's or Bachelor's Degree in related field or equivalent industry experience

Tools

CTMS

Job description

Job Description

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, 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 escalation 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.

Qualifications

• 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.

Work Environment

• This job operates in a professional environment.
• The noise level in this work environment is usually light to moderate.

Physical Demands

• The employee will regularly use hands to reach, handle or feel objects, tools, or controls and talk and hear.
• The employee may frequently stand, walk and sit.
• The employee may occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required include close vision, distance vision and the ability to adjust focus.

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.