[Remote] Clinical Research Associate II

Note: The job is a remote job and is open to candidates in USA. PSI CRO is a leading Contract Research Organization with over 30 years in the industry, focused on delivering quality services across various therapeutic indications. The Clinical Research Associate will manage monitoring tasks and ensure compliance and quality standards in clinical studies while acting as the main communication line between project teams and study sites.ResponsibilitiesAct as the main line of communication between the project team, sponsor, and the siteBuild and maintain a good relationship with the site staff involved in the study conductPrepare, conduct, and report site selection, initiation, routine monitoring and close-out visitsEnsure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site levelEnsure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviationsPerform source data verification and follows up on data queries at site level; review and manage study risks on a site levelEnsure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sitesReview essential study documents and reconcile study Investigator Site File (ISF) / TMF at site levelEnsures quality (data integrity and compliance) at site levelConduct site audit preparation visits and resolve site audit findingsParticipate in study site audits and client onsite visits, as requiredEnsure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ WarehouseConduct project-specific training of site investigatorsSupport preparation of Investigator newslettersAssist Site Management Associates in maintaining study-specific and corporate tracking systems at site levelSupport preparation of draft regulatory and ethics committee submission packagesSupport collection of IP-RED packages at site/country levelFacilitate review and reconciliation of the study TMF on country and site levelsSkillsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceMust have 2+ years of independent on-site monitoring experienceExperience in all types of monitoring visits, in phases I-IIIExperience in Oncology mandatory & GI preferred and/or radio-pharm experience preferredFull working proficiency in EnglishProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travel up to 75%Valid driver's license (if applicable)Located in the Central or West Coast regions is preferredCompany OverviewPSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. It was founded in 1995, and is headquartered in Zug, Zug, CHE, with a workforce of 1001-5000 employees. Its website is https://www.psi-cro.com/.