CRA I / CRA II - Sponsor Dedicated - Bilingual French and English (Home-based - Montreal, Quebec)

📋 Description

• • As a Clinical Research Associate (CRA) I/II at Syneos Health, you will play a pivotal role in the successful execution of clinical trials, ensuring the highest standards of data integrity, patient safety, and regulatory compliance. This is a sponsor-dedicated, home-based position, requiring fluency in both French and English, and is ideal for a motivated professional looking to make a significant impact within the biopharmaceutical industry.
• • You will be responsible for a comprehensive range of site management and monitoring activities, including site qualification, initiation, interim monitoring, and close-out visits. These activities can be performed either on-site or remotely, demanding adaptability and a keen eye for detail. Your judgment and experience will be crucial in evaluating the overall performance of clinical sites and their staff, identifying potential issues, and developing effective action plans to address them.
• • A core aspect of your role will involve ensuring strict adherence to regulatory requirements, ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice), GPP (Good Pharmacoepidemiology Practice), and study protocols. You will maintain a thorough understanding of these guidelines, relevant regulations, and Syneos Health's Standard Operating Procedures (SOPs) and processes.
• • Protecting patient confidentiality and safety will be paramount. You will meticulously verify that the informed consent process has been adequately performed and documented for each participant. Furthermore, you will assess factors that could impact patient safety and the integrity of clinical data, such as protocol deviations, violations, and pharmacovigilance issues, immediately communicating and escalating serious concerns to the project team.
• • In line with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes and conduct Source Document Reviews (SDR) of relevant medical records. You will verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs) and utilize query resolution techniques, both remotely and on-site, to drive timely closure of data discrepancies. Proficiency with electronic data capture systems and hardware/software tools will be essential for effective data review and capture.
• • You may also be involved in the inventory, reconciliation, storage, and security of investigational products (IP). This includes verifying that IP has been dispensed and administered to participants according to the protocol and addressing any issues or risks associated with blinded or randomized information. Your knowledge of GCP/local regulations will ensure the appropriate handling, labeling, import, and return of IP.
• • Maintaining the Investigator Site File (ISF) for accuracy, timeliness, and completeness is a key responsibility. You will reconcile ISF contents with the Trial Master File (TMF) and ensure that investigator sites are aware of and comply with local guidelines and regulations for essential document archiving.
• • Documentation is critical. You will meticulously record your activities through confirmation letters, follow-up letters, trip reports, and communication logs, adhering to SOPs and the CMP/SMP. You will also actively support subject recruitment, retention, and awareness strategies, and diligently enter data into tracking systems to monitor observations, status, and action item resolution.
• • Understanding project scope, budgets, and timelines will be necessary to manage site-level activities and communication effectively, ensuring project objectives and deliverables are met. You must be adaptable and able to quickly adjust to changing priorities in a dynamic environment.
• • You will serve as the primary liaison with study site personnel, potentially in collaboration with a Central Monitoring Associate. Ensuring all assigned sites and project-specific team members are adequately trained and compliant with applicable requirements is vital.
• • Active participation in Investigator Meetings, sponsor face-to-face meetings, global clinical monitoring/project staff meetings, and clinical training sessions is expected. You will also contribute to audit readiness by supporting preparation and follow-up actions.
• • For Real World Late Phase studies, you may operate under the title of Site Management Associate II, with additional responsibilities including comprehensive site support throughout the study lifecycle, understanding local requirements for real-world late-phase study designs, performing chart abstraction and data collection, and collaborating with Sponsor affiliates, Medical Science Liaisons, and local country staff. You may also be requested to train junior staff and proactively identify potential sites based on local knowledge.
• • This role requires a proactive approach, a commitment to quality, and the ability to work independently while being a strong team player. You will contribute to Syneos Health's mission of accelerating the delivery of therapies and improving patient lives worldwide.