Agency Temporary – CRA II, Field Monitor

NantWorks (the “Company”) is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow’s opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries.The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Companymay also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.Position SummaryAgency Temporary – CRA II, Field Monitor will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.Essential FunctionsDevelop, review, and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manualsInterpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.Communicate scientific rationale for assigned studies to team members and clinical sitesServe as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirementsCreate/edit, distribute and collect site feasibility questionnairesOversee and support collection of essential documents during study start-upDetermine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.Collect study and site metrics and maintain study trackers, as neededConduct case report form (CRF) data review and review of source documents, work with sites to resolve data queriesCommunicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visitsPartner with field CRAs and CTAs to resolve issues identified during site visitsWork with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actionsTrain vendors, investigators, and study coordinators on study requirements and provide guidance on site issuesConduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendorTrain sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendorsConduct remote monitoring tasks including reconciliation of site investigational product accountabilityProvide data listings and compile clinical study report documents to support medical writing activitiesCreate and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentationsProvide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.Performs other duties as assigned.Education & ExperienceBachelor’s degree in a clinical research, science, or health-related field with 4 years of experience in a clinical research setting; or a high school diploma with 6 years of experience in a clinical research setting requiredMinimum of 2 years’ experience as a Clinical Research Associate I required Knowledge, Skills, & AbilitiesProficiency in MS Word, Excel, PowerPoint, Outlook, AdobeExcellent written/oral communication skillsStrong organizational and multi-tasking skillsMaintain corporate confidentiality at all timesAbility to set priorities and independent decision makingAbility to work independently as well as in teamsStrong oral and written communication skillsOutgoing and confident demeanorIndependent thinker and persuasive communicatorDetail oriented, with solid organization and time management skillsCompletes projects with reliability and minimal guidanceKnowledge of drug development processComputer literacy: EDC, eTMF, CTMS, etc.Working knowledge of ICH E6, and the Code of Federal RegulationsWorking Environment / Physical EnvironmentMust be able to travel up to 75% of the time based on study requirements.Remote with ability to work flexible hours for various time zones.Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager ap