- Manage 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
- 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.
- Communicate proactively with the Javara administrative team regarding site 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 site
- 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
- 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
- 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
- Collect, process and ship any bodily samples such as blood and urine as required per protocol in compliance with Javara’s SOPs and laboratory guidelines
- Dispense 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 assist the Regulatory Navigator/Manager of Trial Activation with regulatory submissions
- Create source documents 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 EnvironmentThis job operates in a professional environment. This role routinely uses standard office equipment such as computers, laptops, tablets, phones, photocopiers, and printers.
Travel RequirementsThis position may involve travel between research centers, medical practices, and the Javara main office. This position may involve traveling to meetings and some of the meetings may require air travel. Travel within the USA or to other countries for 2-3-day trips may be required at least 6 times per calendar year.
Required Education or Experience
- Bachelor’s degree preferred or equivalent experience
- Work experience in a related field preferred
- Able to use standard office software, as well as proprietary applications unique to the clinical trial industry.
- Must present a pleasant, professional, and helpful demeanor
- Exceptional planning and organizational skills
- Highly motivated to provide exceptional service
- Able to work autonomously or as part of a team
- Able to manage challenging situations and conflicts and resolve problems effectively
- Excellent interpersonal skills with proven written, presentation and verbal competencies
- Able to multi-task and manage multiple priorities while demonstrating excellent customer service behavior
- Refer to ACRP Core Competency Guidelines for CRC’s: www.acrpnet.org/core-competency-guidelines-clinical-research-coordinators-crcs/
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.
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.