Clinical Research Associate - CRA - Pi Health
hace 11 horas
Badajoz
Developing a new medicine today takes 10–12 years and billions of dollars. Much of that time is lost to fragmented clinical trial systems, manual workflows, and disconnected data across sponsors, hospitals, and regulators. Pi Health is building the AI operating system for clinical research to fix this. Our platform, FICS, unifies the entire clinical trial lifecycle—from study startup to patient enrollment to regulatory submission—into a single intelligent system. It replaces fragmented tools such as CTMS, EDC, eTMF, spreadsheets, and email workflows with an integrated platform, enabling pharmaceutical companies to run faster, higher-quality trials and bring new therapies to patients sooner. As our customer base scales across pharmaceutical sponsors and hospital sites, we need a Clinical Research Associate responsible for the oversight of a defined set of clinical trial sites within a region. The CRA will oversee clinical trial sites in multiple countries (Spain, Italy, UK) to ensure compliance with the monitoring plan, protocol, Good Clinical Practice (GCP), and local regulations. The CRA will serve as the primary point of contact for the sites and act as the primary liaison between the sites and Pi Health. The CRA will travel and conduct site visits, oversee essential document collection and review, and prepare trip reports to summarize monitoring activities. Essential Functions of the job: • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance., • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions, • Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious 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 SOPs/processes., • Verifies site processes to obtain informed consent have been adequately performed and documents for each subject, • Assess site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan, • Performs Source Data Review/Source Data Verification for assigned clinical trial sites, • Reviews investigational product inventory, reconciliation and storage at trial sites, ensure GCP guidelines are followed, • Reviews the Investigator Site File for accuracy and completeness, • Provides site and regional metrics into trackers to support project-level report generation, • Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met., • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements., • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings., • Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Minimum of 2 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity, • Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines., • Demonstrated ability in report writing and strong ability to critically understand clinical research documents, • Excellent organizational and communication skills., • Ability to work collaboratively in a fast-paced, dynamic environment., • Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines Computer/Technology Skills: Proficient with Microsoft Office Suite, Project Management tools. Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus. Travel: Up to 75% between multiple countries (Spain, Italy, UK)
