Clinical Research Associate II

Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications.Clinical Research Associate IIRemoteFull TimeExperiencedShareSystImmune is seeking a high quality, ambitious and experienced Clinical Research Associate II (CRA II) to support SystImmune’s clinical trials.

The CRA II is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The CRA II must be self-motivated, independent, and able to work in a small team environment.

The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities.Job Responsibilities:Perform 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 andremotelythrough 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 IP.Qualifications:Bachelor’s degree in health science or related field.2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits.Excellent verbal and written communication skills required.Excellent organizational, multi-tasking and time management skills required.Demonstrated 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%)Compensation and Benefits:The expected base salary range for this position is $80,000 - $110,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.ShareApplyApply for this positionRequired*First Name*Last Name*Email Address*Phone*AddressResume*We've received your resume.

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Citizen/Permanent ResidentNon-citizen allowed to work for any employerNon-citizen allowed to work for current employerNon-citizen seeking work authorizationI am a Canadian Citizen/Permanent ResidentOtherWhat's your highest level of education completed?*No answerGED or EquivalentHigh SchoolSome CollegeCollege - AssociatesCollege - Bachelor of ArtsCollege - Bachelor of Fine ArtsCollege - Bachelor of ScienceCollege - Master of ArtsCollege - Master of ScienceCollege - Master of Fine ArtsCollege - Master of Business AdministrationCollege - DoctorateMedical DoctorOtherCollege or University*Are you 18 years of age or older?*No answerYesNoLinkedIn Profile URL:*Website, blog or portfolio:What languages do you speak fluently?Desired salary*Earliest start date?*Can you work weekends?No answerYesNoCan you work evenings?No answerYesNoCan you work overtime?No answerYesNoIn 150 characters or fewer, tell us what makes you unique. Try to be creative and say something that will catch our eye!150Do you have at least 2+ years of CRA monitoring experience and do you have oncology experience?*We want to evaluate your authentic voice and thinking.

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