Cra Ii- Scra Ii
vor 1 Monat
Updated: TodayLocation: Australia-Asia Pacific - AUS-Home-BasedJob ID: 24004781Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Why Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.Job ResponsibilitiesPerforms site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) 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 serious issues to the project team and develops action plans.Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient.Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.Conducts Source Document Review of appropriate site source documents and medical records.Verifies required clinical data entered in the case report form (CRF) is accurate and complete.May perform investigational product (IP) inventory, reconciliation and reviews storage and security.Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.QualificationsWhat we're looking for• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements• Must demonstrate good computer skills and be able to embrace new technologies• Excellent communication, presentation and interpersonal skills• Ability to manage required travel of up to 75% on a regular basisAdditional Information:Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
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Cra Ii
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Cra Ii- Scra Ii
vor 1 Monat
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