Clinical Research Associate, CRA II – Senior

This is a fully remote position, open to applicants in Canada.

📋 Description

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at designated clinical sites.

• Generate reports for visits and contacts.

• Establish and nurture relationships with sites as their main point of contact.

• Address and resolve questions and issues from the sites.

• Ensure the integrity of the study while fostering positive relationships with site staff.

• Review trial performance and protect the rights and welfare of human subjects in line with the protocol.

• Collaborate with clinical sites to devise patient recruitment strategies that align with enrollment timelines.

• Guarantee adherence to SOPs, protocols, amendments, GCP, and relevant regulatory standards.

• Assess the quality and integrity of reported data, site effectiveness, and drug accountability.

• Oversee the accuracy and completeness of regulatory documentation.

• Conduct verification of site documents.

• Manage site quality and service from identification through to close-out.

⛳️ Requirements

• A minimum of 18 months of direct onsite monitoring experience as a Clinical Research Associate (CRA).

• A Bachelor's degree or equivalent in biological science, pharmacy, or a related health field.

• Excellent interpersonal, written, and verbal communication skills within a matrixed team environment.

• Capability to work independently with urgency and minimal oversight.

• A client-focused mindset with adaptability to new assignments and learning opportunities.

• Proficiency in managing multiple tasks, assessing unpredictable situations, meeting project deadlines, and applying knowledge of study protocols.

• A commitment to honesty and ethical conduct in the workplace.

• Strong computer proficiency, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word.

🏝️ Benefits

• Bonus incentive program.

• Access to world-class technology.

• Training customized to individual experience levels.

• Reduced travel requirements and lower protocol load compared to industry standards.

• Opportunities to engage in various therapeutic areas.

• Career advancement opportunities available.

• Support for career growth through performance discussions and evaluations.

• Pathways for progression into senior CRA roles, line management, Quality, Project Leadership, or other positions.