Job Description:
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.
- Support, guide, train, and mentor 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.
- Adhere to and exemplify Javara Standard Operating Procedures (SOPs), our healthcare partner’s SOPs (if applicable), Good Clinical Practice (GCP), Good Documentation Practices (GDPs), study protocols, clinical trial agreements, and regulations governing clinical research.
- Ensure scientific integrity of data and protect the rights, safety, and well-being of research participants.
- Navigate the resources and workflows within the healthcare and clinical research environments to ensure seamless care for the clinical trial participant, to engage investigators in research daily, and to promote clinical research within the healthcare system.
- 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.
- Conduct and document the informed consent process when delegated to do so by the Principal Investigator in compliance with Javara’s SOPs.
- 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, EKGs, 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.
- Validate and create source documents and document appropriately in source documents and/or medical records (paper, EMR, e-source) per ALCOA+ - data must be attributable, legible, contemporaneous, original, accurate, available, enduring, complete, and consistent.
- 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 CTNs with clinical trial conduct.
- Demonstrate ability to prioritize competing priorities.
Required Qualifications
- Bachelor’s Degree or equivalent related experience.
- Extensive experience in clinical research.
- 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.
Preferred
- Degree in clinical research related major, research certification, or equivalent experience.
- Experience managing clinical research trials across multiple therapeutic areas.
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.
Travel: This position may involve up to 25% travel.
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. Activities, duties, or responsibilities 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.
