Aviator Clinical Trial Navigator (Aviator CTN)

*This role is remote, with an expectation to report in to your local Javara Clinical location and up to 75% travel.

Summary:

The Aviator is responsible for establishing relationships and conducting clinical trials with a new healthcare partner, new location, and/or assisting temporarily with the conduct of trials at an existing care center location. The Aviator CTN is based at a hub care center and travels where needed; mentoring and proctoring the team that will transition into conducting the trials at that location. This position reports to Operations Leader at Hub Care Center Location and closely works with the Principal Investigator or designee. This position is on call to support clinical trial needs across our network of care centers/potential care centers.

Essential Duties and Responsibilities:

• Promote the mission of Javara with a primary guiding principle of patient safety and well-being and building and maintaining a culture that combines the highest standard of integrity with excellence to all those Javara serves.

• Implements and coordinates research study procedures and activities at the Base Care center/Hub Location, developing research care center locations, and other research care center locations based on need.

• Supports, guides, trains, and mentors other clinical research team members on study activities for the successful management of clinical trials according to GCP, federal regulations, and Javara SOPs at all locations.

• Ensures successful transition from Aviator team to permanent team at new and developing healthcare partners and clinic locations.

• Assists Investigator Relations team in developing naive investigators at developing research care centers.

• Supports the development and growth of new and existing research care center locations, clinical trial navigators, and the relationship with our healthcare partners.

Specific Responsibilities

• Travel to care center locations/potential locations and manage clinical research studies as the lead CTN.

• At the hub/primary care center location support clinical trial conduct as a backup/support CTN.

• Train, guide, and proctor the clinical research team members that will assume responsibility for the trial when the aviator CTN returns to their hub/primary care center location.

• Appropriately document all training/proctoring activities.

• Adhere to and exemplify Javara Standard Operating Procedures (SOPs), our healthcare partner’s SOPs, Good Clinical Practices (GCPs), Good Documentation Practices (GDPs), study protocols, clinical trial agreements, and regulations governing clinical research.

• Mentors and supports other clinical team members and acts as a proctor assessing the knowledge, skills and abilities of the clinical research team.

• Works with the project management team to proactively follow through on the trial activation process.

• Assists with the quality review of study activities at hub care center and other assigned research locations.

• Contributes to the development of new processes, procedures, tools, and training to improve clinical trial conduct.

• Ensure scientific integrity of data and protect the rights, safety, and well-being of research participants.

• Navigate the resources and workflow within the healthcare and clinical research environment to ensure seamless care for the clinical trial participant, to engage investigators in research daily and to promote clinical research within the healthcare system.

• Identify strategies to increase efficiencies at new and developing healthcare partners and clinics.

• Communicate proactively with the Javara administrative team regarding care center operations including screening and enrollment numbers, investigator and research participant engagement, ancillary procedures, protocol conduct and financial information.

• Ensure all data/information is accurate for payments to and from Javara, as well as, source documentation data, enrollment numbers and any other data collected at the care center.

• Understand and implement a patient engagement plan with appropriate documentation or work with the engagement center to identify and contact potential research participants, and then screen and enroll eligible participants in suitable clinical research studies.

• Conduct and document the informed consent process when delegated to do so by the Principal Investigator in compliance with Javara’s SOPs.

• Demonstrate competency with respect to both clinical trial conduct and specific research studies with investigators, healthcare partners, sponsor, CRO, research team, and potential and active research participants.

• Coordinate research participant visits and study related procedures according to study protocol windows and study team schedules. This may involve handling travel logistics for research participants.

• Ensure reminder communications (phone, text or email as requested by the participant) are conducted to promote show rate and compliance or work in collaboration with the engagement team to do so.

• Conduct clinical research study visits/procedures per protocol requirements. This may include but is not limited to: obtaining vital signs, height, weight, EKG’s, spirometry, medical history, medications, adverse events, and labs as well as administering questionnaires and diaries.

• Collect, process, and ship any bodily samples such as blood and urine as required per protocol in compliance with Javara’s SOPs, laboratory guidelines, and International Air Transport Association (IATA) standards.

• Dispense and document investigational product and other research study supplies in an accountable manner in accordance with study requirements, institutional requirements, investigator approval and regulations.

• Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements.

• Assist with Integrating clinical research as a care option within the healthcare system.

• Monitor and report adverse events, serious adverse events and protocol deviations to the investigator, sponsor, and IRB in compliance with Javara’s SOPs.

• Know and understand regulatory requirements, maintain files and documents, and work with the Javara central regulatory team to maintain the regulatory/study file documents.

• Validate eSource and create paper source documents and document appropriately in source documents and /or medical records (paper, EMR, e-source) per ALCOA : data is attributable, legible, contemporaneous, original, accurate, available, enduring, complete, and consistent.

• Complete and maintain case report forms (paper or electronic) and answer queries regarding study data per FDA regulations and in a timely manner, clinical trial agreement and protocol requirements.

• Prepare for and participate in routine monitoring visits, internal and external audits, and inspections.

• Ensure study documentation is audit ready in the event of monitoring, audits and inspections.

• Demonstrate the ability to manage high volume and complex trials and /or assist other CTN’s with clinical trial conduct.

• Demonstrate ability to prioritize competing priorities.

• Assist with additional projects as requested by the Operations Leader at Hub/Primary Care Center.

Qualifications:

Required

• Bachelor’s Degree or equivalent related experience.

• 5 years of experience in clinical research, as a Clinical Research Coordinator/Clinical Trial Navigator.

• Experience successfully mentoring clinical research team members.

• Able to utilize standard office software/technology, as well as platforms unique to the clinical trial industry and able to mentor others on the office software/technology/platforms.

• Must present a pleasant, professional, and helpful demeanor.

• Must complete Navigator Foundations, Proctoring Training, Aviator Training, Proctoring and Mentoring Checklist, QA Certification (including SOP Knowledge Assessment) at Javara.

• Must be recommended by Javara Operations Leader or similar recommendation from previous manager/leader.

Preferred

• Degree in clinical research related major or research certification or equivalent experience.

• Experience managing clinical research trials across multiple therapeutic areas.

Work Environment:

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

• This job operates in a professional environment.

• The noise level in this work environment is usually light to moderate.

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.

• 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 will ascend or descend ramps and/or stairs using feet and legs. Hands and arms may be used for balance.

• 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.

Position Type: This is a remote position, full-time, exempt position.

Travel: This position may involve up to 75% travel and when not traveling working remote/home. Travel would include hub site as a travel location.

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.

Job Type: Full-time

Pay: $70,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• What are your salary expectations?

Education:

• High school or equivalent (Preferred)

Experience:

• Clinical Research Coordinator/Clinical Trial Navigator: 5 years (Preferred)

Willingness to travel:

• 75% (Required)

Work Location: On the road