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Sr Clinical Research Associate

55 minutes ago

Toronto, Canada Syneos Health Full time

Sr Clinical Research Associate - Sponsor Dedicated - Cardiology (Home-Based in Ontario) Apply for the Sr Clinical Research Associate - Sponsor Dedicated - Cardiology (Home-Based in Ontario) role at Syneos Health. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success, translating clinical, medical affairs and commercial insights into outcomes. Our Clinical Development model places the customer and the patient at the center of everything we do. Job Responsibilities Perform site qualification, initiation, interim monitoring, site management, and close‑out visits (on‑site or remotely), ensuring regulatory, ICH‑GCP, and GPP compliance. Verify informed consent processes, protect patient confidentiality, and assess factors that might affect safety and data integrity. Review site source documents, verify clinical data in CRFs, resolve queries, and support electronic data capture compliance. Handle investigational product inventory, reconciliation, and storage security, including blinding and randomization requirements. Review Investigator Site Files for accuracy, reconcile with Trial Master Files, and ensure correct archiving. Document activities via letters, trip reports, logs, and other required project documents; support recruitment and retention strategies. Manage site‑level activities, communication, and project objectives while adapting to changing priorities. Act as primary liaison with site personnel and coordinate with Central Monitoring Associates. Attend investigator meetings, sponsor face‑to‑face meetings, and global monitoring/project staff meetings. Provide guidance on audit readiness and support audit preparation and follow‑up actions. Mentor junior CRAs, conduct training and sign‑off visits, and perform lead tasks under experienced supervision. For Real World Late Phase studies, support site management, chart abstraction, and regulatory activities; develop consent forms and contribute to RFPs and budgeting. Qualifications Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience. Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements. Proficient computer skills and ability to adopt new technologies. Excellent communication, presentation, interpersonal, and critical‑thinking skills. Capability to manage travel up to 75% of the time. Additional Information Tasks, 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 and responsibilities. Equivalent experience, skills, and/or education may also be considered. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations as appropriate. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology #J-18808-Ljbffr