Clinical Research Associate
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Job Description
Clinical Research Associate ensuring compliance and site management in biopharmaceutical studies across Canada. Conducting monitoring visits and supporting patient recruitment while adhering to regulatory requirements.
Responsibilities:
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; 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 the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on-site
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements
- Supports subject/patient recruitment, retention and awareness strategies
Requirements:
- 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 other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Basic level of critical thinking skills expected
- Ability to manage required travel of up to 75% on a regular basis
Benefits:
- Health insurance
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Flexibility in working hours
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