Remote Clinical Research Associate I or II

Summary

The job is for a Clinical Research Associate (CRA) in a training role, responsible for site management activities, data review, and supporting other CRAs. The position requires a college diploma/degree and 1-3 years of related experience, with additional assets such as SoCRA, CCRA, or ACRP certification.

Requirements

• The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience
• The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results
• Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results

Responsibilities

• Support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge
• Provide monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance
• Conduct remote data review of EDC, CTMS, RBM and other clinical systems to ensure alignment with SOPs, study guidelines and GCP best practices
• Identify trends within and across study sites and escalate findings appropriately
• Conduct remote site contacts which could include remote site initiation, monitoring and close out visits
• Conduct onsite activities such as feasibility, qualification, initiation, monitoring and close out visits under supervision
• Remotely monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life cycle
• Support preparation for audit and required follow-up actions
• Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria

Preferred Qualifications

SoCRA, CCRA and/or ACRP certification/designation is an asset

Benefits

• Home-based
• Regular travel