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Key AccountabilitiesEnsuring regulatory, ICH-GCP and protocol compliance.Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processesPer the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulationsConducts source document review and verification of appropriate site source documents and medical recordsVerifies required clinical data entered in the Case Report Form (CRF) is accurate and completeManages reporting of protocol deviations and appropriate follow upDocuments activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMPConducts follow up for escalated adverse event monitoring (AEM) report queriesCollaborates with primary Site Manager who will act as the primary liaison with site personnelThe IndividualA minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experienceExperience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practiceProficiency in local language is requiredEnglish proficiency is requiredAbility to manage required travel of on a regular basisSkillsNetworking and relationship building skillsAbility to communicate effectively and appropriately with internal and external stakeholdersAbility to adapt to changing technologies and processesEffectively overcoming barriers encountered during the implementation of new processes and systemsExcellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organizationIdentifies and builds effective relationships with investigator site staff and other stakeholdersMust demonstrate good computer skills and be able to embrace new technologies
