Remote Senior Clinical Research Associate/Clinical Research Associate II

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading company in clinical research aiming to improve the world's health. They are seeking a Senior Clinical Research Associate responsible for site management, monitoring, and ensuring reputed company execution of reputed company in accordance with regulations and standards.ResponsibilitiesEnsure reputed company conduct of reputed company in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to reputed company project goals, timelines and reputed companyManage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and reputed company deliverables are metDuring study conduct, serve as the primary reputed company of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure reputed company of site deliveryreputed company with the study team as needed, facilitate information reputed company between members of the study team, vendors and assigned investigator sitesPartner with SCP to reputed company investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; reputed company protocol training to, and address protocol reputed company questions from the investigator site staff reputed company required, including discussions on reputed company/anticipated operational and clinical trial risksAttend investigator meeting reputed company required (virtual or F2F). reputed company enrollment support and ensure reputed company by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site levelConduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, reputed company Operating Procedures (SOPs) and commensurate with emerging issues and technologiesMonitor site level adverse events (reputed company) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to reputed companySubmit reputed company required reports, documentation, updates and tracking reputed company required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study reputed company and metricsIdentify and resolve investigator site issues reputed company required timeframes; agree and reputed company corrective and preventative actions with investigator and site personnel to reputed company reputed company issues and to prevent recurrence/persistence of issuesResolve data queries reputed company required timelines, prepare investigator site reputed company-out plan and conduct reputed company-out activities reputed company required timelinesEnsures adequate reputed company of the investigational product at the investigator site, including receipt, handling, reputed company, storage conditions, and destruction activitiesSupport database release as neededMay undertake the responsibilities of an unblinded monitor where appropriateMaintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site teamreputed company with investigator site heath care professionals in a manner which enhances sponsors credibility, scientific leadership and in order to facilitate sponsors clinical development goalsSupport the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigatorsreputed company reputed company Event (QE) remediation, reputed company applicableServe as a reputed company of contact for audit conduct, and reputed company Audit Observation corrective reputed company/preventive reputed company (CAPA) development and checks, reputed company applicableReports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)Partners with SCP and Country Study Operations Manager (SOM)reputed company required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)May reputed company as a Mentor for Clinical Research AssociatesSkillsMinimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or reputed company organizationExtensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulationsMust be fluent in English and in the reputed company language(s) of the .