CRA II

Overview Description CRA II - Sponsor dedicated - Brazil Home Based. Syneos 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 places the customer and patient at the center of everything we do. We aim to simplify and streamline our work to be easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies informed consent processes and documentation for each subject/patient; protects confidentiality and assesses factors affecting safety and data integrity at investigator/physician sites. Per the CMP/SMP: assesses site processes, conducts Source Document Review, verifies data in the CRF, applies query resolution remotely and on site, and ensures timely closure. Uses hardware/software to support data review and ensures IP is managed per protocol. Verifies IP labeling, import, release/return, and related activities. Routinely reviews ISF for accuracy and completeness; reconciles ISF with TMF and ensures archiving of essential documents per local guidelines and regulations. Documents activities via letters, trip reports, logs, and other project documents; supports subject recruitment/retention and enters data into tracking systems. Manages project scope, budgets, and timelines for site-level activities; adapts to changing priorities to meet goals. Acts as liaison with study site personnel and ensures training/compliance of assigned sites and project team members. Prepares for and attends Investigator Meetings or sponsor meetings; participates in global clinical monitoring/project staff meetings and clinical training sessions as required. Supports audit readiness and follows up on required actions; maintains knowledge of ICH/GCP and applicable SOPs. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II and may include site support across the study lifecycle, chart abstraction, and collaboration with Sponsor affiliates, MSLs, and local staff. May train junior staff and identify out-of-scope activities for the Lead CRA/Project Manager. May suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and HCP associations. Qualifications 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 regulatory requirements Strong computer skills and ability to adopt new technologies Excellent communication, presentation and interpersonal skills Ability to travel up to 75% regularly US ONLY: As part of employment, you may be deployed to sites that require certain information for facility access. Compliance with Site requests is required as a condition of employment. Failure to provide requested information may result in site access issues. Additional Information Miscellaneous #LI-SA2 Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health: EEO / Equal Opportunity Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require reasonable accommodation to participate in the application process, please contact us at: #J-18808-Ljbffr