Research Assistant

Oncology protocols are clinically dense, so building real familiarity with the state of the disease, treatment history, and clinical rationale behind each assigned protocol, not just the task list, is part of the job from day one. In this patient population, a missed detail is a safety issue before it's ever a data issue. Valkyrie's care model is also white glove. Participants and their families are never routed around or told no when they hit a logistical obstacle, and the RA is expected to help remove those barriers, escalating to the CRC or Team Lead when a resolution is beyond their current scope.

This is the individual contributor entry point into the Clinical Research Coordinator job family. The band spans Research Assistants who are new to clinical research through Senior Research Assistants operating with greater independence and taking on more complex protocol responsibilities. Progression through the band, and eventual readiness for the CRC role, is determined by the Flourish Research CRC Competency Assessment.

Essential Job Functions

• Read and understand protocols to help accomplish protocol-specified patient visits and procedures as directed by assigned Team Lead or CRC.
• Under the direction of assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results, and other study-related information per federal regulations, protocol requirements, and GCPs.
• Obtain patient informed consent according to federal regulations, GCPs, and IRB requirements.
• Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, and GCP guidelines.
• Assist in the scheduling, preparation, and conducting of patient visits according to protocol requirements and timelines as directed by assigned Team Lead or CRC.
• Under close supervision, maintain accurate and complete written source documentation of patient visits and protocol-related activities.
• Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor or CRO.
• Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements.
• Promptly report adverse events to the Team Lead, CRC, or other supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
• Assist in the accountability of clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate quantities required for the study.
• Maintain ongoing communication with the Team Lead, CRC, Clinical Team Manager, Principal Investigator, and other persons assisting with the study, and document these communications according to protocol requirements and Flourish Research policies.
• Attend required training courses/conferences to stay current and aware of changing federal regulations and Flourish Research policies.
• Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research.
• Perform all study-related duties in a time- and cost-effective manner in adherence with Flourish policies.
• Perform all duties in a safe and prudent manner.
• Represent Flourish Research in a professional and courteous manner when interacting with Flourish staff, sponsors, IRBs, patients/subjects, and nursing and medical staff members of various clinics, hospitals, and physicians' offices.
• Additional duties as assigned by management.

Physical Job Requirements

• Work is normally performed in a typical interior/office work environment.
• Local travel may be required.
• Exposure to human bodily fluids.
• Laboratory processing procedures.
• Participant care.
• Extensive computer use.
• Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
• Occasional night and weekend work schedules.
• Ability to drive and daily availability of an automobile.