Clinical Research Assistant

3 days ago


Jupiter, United States Eximia Research Full time

Clinical Research AssistantThe Clinical Research Assistant assists the Clinical Operations Team at our Encino, CA location in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.Role & Responsibilities:Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Eximia Clinical Network’s SOPsPerform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulationsWith supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulationsPerform and/or verify equipment calibration and maintenanceProcess, package and ship laboratory specimens as required per protocol and IATA regulations, if applicableTrack, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trialEnter source data into the sponsor's and/or vendor’s data portal and resolve basic queries in a timely manner under the direction of the Clinical Research CoordinatorEffectively communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research TeamUnderstand good documentation in accordance with ALCOA-C principles when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research CoordinatorUnderstand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjectsUnderstand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trialUnderstand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in personMaintain confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Network confidential informationAbility to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research TeamCleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as neededPrepare source document charts, copy and/or file medical records and study related documents as required.Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.Other duties as assignedQualificationsEducation/Experience:High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industryRequired Licenses/Certifications:Phlebotomy if applicable and required by state lawIntramuscular dose administration and preparation if applicable and required by state lawRequired Skills:Demonstrated knowledge of medical terminologyDemonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.Understanding of verbal, written, and organizational skillsDemonstrated ability to work as a team playerDemonstrated ability to read, write, and speak EnglishDemonstrated ability to multi-taskDemonstrated ability to follow written guidelinesDemonstrated ability to be flexible/adapt as daily schedule may change rapidlyRequired Physical Abilities:Sit or stand for long periods of timeCommunicate in person and by a telephoneLimited to moderate walking requiredLimited to lifting up to 30 pounds



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