Sr CRA - Sponsor Dedicated - Liver & Rare Disease& Diabetes/Obesity-Canada -Bilingual (French &English)

📋 Description

• • Syneos Health is seeking a dedicated and experienced Senior Clinical Research Associate (Sr. CRA) to join our dynamic team, focusing on Sponsor-dedicated studies within the critical therapeutic areas of Liver Disease, Rare Diseases, Diabetes, and Obesity across Canada.
• • This role is pivotal in ensuring the successful execution of clinical trials by meticulously managing and monitoring investigative sites, guaranteeing adherence to the highest standards of regulatory compliance, Good Clinical Practice (GCP), and protocol requirements.
• • As a Sr. CRA, you will be instrumental in performing comprehensive site qualification, initiation, interim monitoring, site management, and close-out visits. These activities can be conducted either on-site or remotely, demanding adaptability and a strong understanding of diverse monitoring methodologies.
• • You will exercise sound judgment and leverage your extensive experience to evaluate the overall performance of clinical sites and their staff. This includes identifying potential risks, immediately communicating serious issues to the project team, and developing robust action plans to mitigate them.
• • Maintaining a current and thorough understanding of ICH/GCP Guidelines, relevant national and international regulations, and Syneos Health’s Standard Operating Procedures (SOPs) and processes is a core responsibility.
• • A critical aspect of your role will involve verifying that the informed consent process has been adequately performed and meticulously documented for each subject/patient, demonstrating a profound respect for patient rights and confidentiality.
• • You will be responsible for assessing factors that could impact subject/patient safety and the integrity of clinical data at investigator sites, including protocol deviations, violations, and pharmacovigilance issues.
• • In alignment with the Clinical Monitoring/Site Management Plan (CMP/SMP), you will assess site processes, conduct thorough Source Document Reviews (SDR) of relevant medical records, and verify the accuracy and completeness of clinical data entered into Case Report Forms (CRFs) against these source documents.
• • You will apply advanced query resolution techniques, both remotely and on-site, providing essential guidance to site staff to drive query closure within agreed-upon timelines, ensuring data quality and integrity.
• • Proficiency in utilizing available hardware and software for effective clinical study data review and capture is essential, including verifying site compliance with electronic data capture requirements.
• • You may be tasked with managing investigational product (IP) inventory, reconciliation, and reviewing its storage and security, ensuring it is dispensed and administered to subjects/patients according to the protocol.
• • A key responsibility includes verifying IP handling, including labeling, importation, and release/return, in strict accordance with GCP and local regulations, as well as organizational procedures.
• • You will routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconciling its contents with the Trial Master File (TMF) and ensuring the investigator site understands the archiving requirements for essential documents.
• • Documentation of all activities is crucial, including confirmation letters, follow-up letters, trip reports, and communication logs, all maintained per SOPs and the CMP/SMP.
• • You will actively support subject/patient recruitment, retention, and awareness strategies, contributing to the overall success of the trial.
• • Entering data into tracking systems to monitor observations, ongoing status, and action items through to resolution is a required daily task.
• • Understanding project scope, budgets, and timelines for your activities and those of your colleagues within the clinical team is vital for managing site-level activities and communication to meet project objectives.
• • You must possess the ability to quickly adapt to changing priorities and maintain focus on achieving goals and targets in a fast-paced environment.
• • You will serve as the primary liaison with study site personnel, or in collaboration with Central Monitoring Associates, ensuring all assigned sites and project-specific site team members are adequately trained and compliant with all applicable requirements.
• • Preparation for and active participation in Investigator Meetings and sponsor face-to-face meetings are expected.
• • You will participate in, and potentially lead, global clinical monitoring and project staff meetings, including sponsor representation, and attend clinical training sessions as required by the project.
• • Providing guidance at both the site and project level towards audit readiness standards and supporting preparation for audits and subsequent follow-up actions is a key contribution.
• • For experienced individuals, this role may involve providing direct supervision, training, and mentorship to more junior CRAs, including conducting training and sign-off visits.
• • You may also be mentored and assigned lead tasks under the supervision of an experienced Clinical Operations Lead (COL) or operational line manager, potentially including participation in business development proposals and defense meetings.
• • For Real World Late Phase (RWLP) studies, you may operate under the title of Sr. Site Management Associate II, with additional responsibilities including site support throughout the study lifecycle, knowledge of local RWLP designs, chart abstraction, and data collection.
• • Collaboration with Sponsor, affiliates, medical science liaisons, and local country staff will be integral to success.
• • You will proactively identify and communicate out-of-scope activities, suggest potential sites based on local knowledge, and identify operational efficiencies and process improvements.
• • Development of study and country-level informed consent forms, collaboration with the RWLP Regulatory team, and participation in bid defense meetings are also potential aspects of the role.
• • Providing input into Requests for Proposals (RFPs), scope, and budgeting, and developing site management strategies are key contributions for RWLP studies.
• • Participation in Case Report Form design and edit check development may also be required.