Clinical Research Associate I in Late Phase

OverviewClinical Research Associate I in Late Phase - Sponsor dedicated based in Paris Area (Boulogne Billancourt)Join to apply for the Clinical Research Associate I in Late Phase - Sponsor dedicated based in Paris Area (Boulogne Billancourt) role at Syneos Health.DescriptionSyneos 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.WORK HERE MATTERS EVERYWHERE.ResponsibilitiesPerforms site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacovigilance/Pharmacoepidemiological Practices (GPP) and protocol compliance. Evaluates site performance and staff, provides recommendations for site-specific actions, communicates/escalates serious issues, and develops action plans with guidance. Maintains knowledge of ICH/GCP Guidelines, applicable regulations, and SOPs. Verifies informed consent processes for each subject/patient and protects confidentiality. Assesses factors affecting subject safety and data integrity at investigator sites such as protocol deviations and pharmacovigilance issues.Assesses CMP/SMP processes, conducts Source Document Review, verifies CRF data accuracy, applies remote and on-site query resolution, and supports data capture and data quality. Ensures site compliance with electronic data capture requirements.May perform investigational product (IP) inventory, reconciliation, storage/security review, and ensures IP dispensing per protocol. Ensures proper labeling, import, and release/return of IP per governance.Routinely reviews Investigator Site File (ISF) for accuracy and timeliness, reconciles with Trial Master File (TMF), and ensures archiving of essential documents per guidelines.Documents activities via letters and logs; supports subject recruitment and retention; 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 with oversight from the Lead CRA.Acts as primary liaison with project site personnel or in collaboration with other CRAs or Central Monitoring Associates; ensures training and compliance of site team members.Prepares for and attends Investigator Meetings and sponsor meetings; participates in global monitoring/project staff meetings and attends clinical training as required.Supports audit readiness and follow-up actions at the site and project level.For Real World Late Phase, CRA I will use the business card title of Site Management Associate I. Responsibilities include site support throughout the study lifecycle, knowledge of local real-world late-phase study requirements, chart abstraction, data collection, and collaboration with sponsor affiliates and local country 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 applicable regulatory requirementsStrong computer skills and openness to new technologiesExcellent communication, presentation and interpersonal skillsAbility to travel up to 75% regularlyUS ONLY: Advisory information on site access and privacy notices; comply with site requests as a condition of employment. Non-compliance may affect entry to sites.Seniority levelEntry levelEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyGet notified about new Clinical Research Associate jobs in Montrouge, Île-de-France, France. Boulogne-Billancourt, Île-de-France, France 2 days agoAdditional information: This description may include references to other roles and general company information for context. #J-18808-Ljbffr