CRA II, Oncology ** Hybrid SPAIN **

Updated: YesterdaySolicitar este puesto es sencillo. Desplácese hacia abajo y haga clic en "Solicitar" para ser considerado para esta posición.Location: ESP-Madrid-HybridJob ID:25104564Syneos 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.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team 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 EVERYWHEREWhy 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 (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site and staff performance and provides recommendations; communicates/escalates serious issues and develops action plans. Maintains knowledge of ICH/GCP Guidelines, applicable guidance, regulations and SOPs.Verifies informed consent processes and documentation for each subject/patient. Protects confidentiality and assesses factors affecting subject safety and data integrity (e.g., protocol deviations and pharmacovigilance issues).Per CMP/SMP: Assesses site processes, conducts Source Document Review, verifies CRF data accuracy, applies remote and on-site query resolution, and ensures adherence to electronic data capture requirements.May perform IP inventory, reconciliation and storage/security reviews. Ensures IP dispensing and administration per protocol; handles IP labeling, importation and release/return per GCP/local procedures.Routinely reviews ISF for accuracy and timeliness; reconciles with TMF. Ensures archiving of essential documents per guidelines/regulations.Documents activities via letters, reports, logs and other required documents; supports recruitment, retention and awareness; enters data into tracking systems to monitor observations and action items.Understands project scope, budgets and timelines; manages site-level activities and communications to meet objectives; adapts to changing priorities.Acts as liaison with study site personnel and ensures training and compliance of site team members with applicable requirements.Prepares for and attends Investigator Meetings; participates in global monitoring/project meetings and attends required training per project requirements.Provides guidance toward audit readiness and supports audit preparation and follow-up actions.Maintains knowledge of ICH/GCP guidelines, relevant regulations and SOPs; completes required training. For Real World Late Phase, the CRA II may use Site Management Associate II title with additional responsibilities including lifecycle site support, chart abstraction, and collaboration with Sponsor affiliates and local staff.QualificationsBachelor’s degree or RN in a related field or equivalent combination of education, training and experienceKnowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirementsStrong computer skills and ability to adapt to new technologiesExcellent communication, presentation and interpersonal skillsAbility to travel up to 75% regularly1 year oncology experience is required.+1 year experience in on-site monitoring visit.Get to know Syneos HealthOver 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 what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. InformationTasks, 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. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes as equivalent to the qualifications described above. Nothing herein should be construed to create an employment contract. This description complies with laws in the countries where it operates, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations provided where appropriate.SummaryRoles within Clinical Monitoring/CRA are responsible for overseeing clinical research studies by monitoring data and processes from a centralized location, including remote monitoring to verify regulatory and protocol compliance. Utilizes data analytics and risk-based monitoring to identify issues and trends, and collaborates with site teams to enhance quality monitoring and trial success.Get to know Syneos HealthAt Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway and consider transferable skills. We also invite you to join our Talent Network to stay connected to opportunities.Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization. Contact: Phone 919 876 9300, Fax 919 876 9360, Toll-Free 866 462 7373Syneos 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. xsgfvud If you require reasonable accommodation to complete the application process, please contact #J-18808-LjbffrHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.