Senior Clinical Research Associate – FSP

🕒 August 27

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 39%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage assigned investigator sites from site activation through database lock • Conduct site management, onsite and remote/electronic monitoring, site initiation, routine monitoring and site closure • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, GCP and sponsor standards • Serve as primary contact for assigned investigator sites and manage investigator-site relationships • Collaborate with Site Care Partners, study teams, vendors, investigators and site staff • Provide site personnel coaching, training and protocol training • Support enrollment and recruitment initiatives and resolve activation and recruitment issues • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply information and study metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and, where appropriate, undertake unblinded monitor responsibilities • Support patient safety, eligibility and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable

🎯 Requirements

• Minimum 3 years relevant experience in clinical research site monitoring • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Fluency in English and in the native language(s) of the country they will work in • Ability to travel 60–80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent • Knowledge of the product, protocol and therapy area sufficient for discussions with investigators and site teams

🏖️ Benefits

• Travel opportunity of 60–80% associated with the role

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