- Manage clinical research studies and adhere to Javara Standard Operating Procedures (SOPs), the healthcare partner’s SOPs, Good Clinical Practices (GCPs), study protocols, clinical trial agreements, and regulations governing clinical research
- Coordinate research participant visits and study related procedures according to study protocol windows and study team schedules, which may involve handling travel logistics for research participants; ensure reminder communications (phone, text or email) are sent to promote research participant show rate and compliance; identify and outreach to prospective patients; prepare study visit materials such as lab kits, study forms and diaries for participant visits
- Conduct clinical research study visits/procedures per protocol requirements. This may require obtaining vital signs, height, weight, EKG’s, spirometry, medical history, medications, adverse events and labs as well as administering questionnaires and diaries
- 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
- Create and implement a patient engagement plan to identify and contact potential research participants, and then screen and enroll 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
- Collect, process and ship any bodily samples such as blood and urine as required per protocol in compliance with Javara’s SOPs, IATA guidelines and laboratory guidelines
- Dispense investigational products 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, Javara Director and IRB in compliance with Javara’s SOPs
- Know and understand regulatory requirements, maintain files and documents, and assist the Manager of Trial Activation with regulatory submissions
- Create source documents as needed and document appropriately in source documents and /or medical records (paper, EMR, e-source) per ALCOA: data is attributable, legible, contemporaneous, original and accurate
- Complete and maintain case report forms (paper or electronic) and answer queries regarding study data per FDA regulations, clinical trial agreement and protocol requirements
- Prepare 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
- Assist with additional projects as requested by Director/ Associate Director of Clinical Research Operations
- Work with the Director/Associate Director of Clinical Trial Operations to ensure that all functions are aligned with the company’s strategic mission, values, and vision
Work EnvironmentThe 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
- 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
Travel RequirementsThis position may involve up to 25% travel within the USA and other countries for 2-3 day trips at least 6 times per year. Travel includes trips between research centers, medical practices, and Javara’s headquarters office.
Required Education or Experience
- Bachelor’s degree
- At least 5 years of experience in healthcare and/or related field
- Knowledgeable of study specific protocols as well as regulations and guidance for the conduct of clinical trials per the ACRP Core Competency Guidelines
- Ability to 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
- Exceptional time management, problem-solving, planning and organizational skills
- Strong interpersonal skills with proven written and verbal communication skills
- Ability to work autonomously or as part of a team
- Ability to manage multiple priorities while demonstrating excellent client service
- Fluent in the use of Microsoft Office applications
- Comfort and ability in the use of standard office equipment such as computers, laptops, tablets, phones, photocopiers, and printers
- Bachelor’s degree in related field
- Clinical Research Coordinator Certification from the ACRP
Other DutiesThis 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.