• 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 • Mentors and supports other study team members and assists with the quality review of study activities • Contributes to the development of new processes, procedures, tools and training to improve clinical trial conduct • Complete or assist with completion of feasibility questionnaires as needed • 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 the Director of Clinical Research Operations
Source: Indeed.com
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