- Promoting the mission of Javara with a primary guiding principle of research participant safety, research participant well-being, and doing so with integrity and excellence to those we serve.
- Assist the CTNs in the conduct of clinical research studies and adhere to Javara Standard Operating Procedures (SOPs), our healthcare partner’s SOPs, Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and regulations governing clinical research.
- Assist in coordinating 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.
- Assist with reminder communications (phone, text or email as requested by the participant) to promote show rate and compliance.
- Assist CTNs, as delegated, in the conduct of clinical research study visits/procedures per protocol requirements. This may include but not limited to obtaining vital signs, height, weight, EKG’s, spirometry, medical history, medications, and labs as well as training patients on questionnaires and diaries.
- Assist CTNs, as delegated, in the collection, processing and shipping of any bodily samples such as blood and urine as required per protocol in compliance with Javara’s SOPs, IATA guidelines and laboratory guidelines.
- Obtain office and clinical supplies (such as dry ice), when needed.
- Assist CTNs in maintaining regulatory files, source documents, and any other research related documents.
- Assist CTNs with preparation for routine monitoring visits, internal and external audits, and inspections.
- Assist CTNs in identification and outreach to prospective patients
- Assist with additional projects as requested by the site research team.
- Monitor temperature logs and report abnormalities to CTNs in timely manner.
- Assist with case report form data entry, query resolution and regulatory reporting requirements.
- Assist in preparing study visit materials such as lab kits, study forms and diaries for scheduled participant visits.
Work EnvironmentThis job operates in a professional environment. This role routinely uses standard office equipment such as computers, laptops, phones, photocopiers, printers, and fax machines.
Travel RequirementsThis position may involve travel between research centers, medical practices, and the Javara main office.
Required Education or Experience
- Bachelor’s degree preferred, Certified Medical Assistant or equivalent experience
- Work experience in a related field preferred
- Able to use standard office software
- Must present a pleasant, professional, and helpful demeanor
- Exceptional planning and organizational skills
- Highly motivated to provide exceptional service
- Excellent written and verbal communication skills
- Able to work autonomously or as part of a team
- Able to manage challenging situations and conflicts and resolve problems effectively
- Able to multi-task and manage multiple priorities while demonstrating excellent customer service behavior
- Excellent interpersonal skills with proven written, presentation and verbal competencies
Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for 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.
EOE Statement: We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.