[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in innovative cancer treatments. They are seeking a Senior Clinical Research Associate (CRA) to manage and oversee clinical study sites, ensuring data quality and patient safety in accordance with regulations and guidelines.ResponsibilitiesPerform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out VisitsPrepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sitesResponsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drugAssist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communicationLiaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queriesMaintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondenceIdentify and complete follow-up of SAEs at study sitesAssist with data listing, data coding, patient profile reviews, database lock, and site close-out activitiesEnsure appropriate and timely submission of documents to the Trial Master FilePerform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IPSkillsBachelor's degree in health science or related field5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visitsExcellent verbal and written communication skills requiredExcellent organizational, multi-tasking and time management skills requiredDemonstrated experience developing/maintaining site relationships and securing complianceWorking knowledge of International Conference on Harmonization Good Clinical Practice guidelinesExperienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)Ability to travel as required (50-75%)Benefits100% paid employee premiums for medical/dental/visionAlso STD, LTDA 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years15 PTO days per yearSick leavePlus 11 paid holidaysCompany OverviewSystImmune is a biotechnology company. It was founded in 2014, and is headquartered in Redmond, Washington, USA, with a workforce of 51-200 employees. Its website is https://www.systimmune.com.