Clinical Research Associate II

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

📋 Description

• Proactively address clinical site issues related to studies and take the initiative to suggest and communicate corrective measures.

• Oversee activities carried out by clinical investigative sites to ensure successful protocol implementation.

• Guarantee compliance with federal and local regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards.

• Conduct site qualification, initiation, interim monitoring, and final closeout visits for Phase I to III studies.

• Supervise site personnel activities and inspire them to achieve study objectives.

• Actively manage sites and execute action plans to maintain compliance.

• Ensure readiness for regulatory inspections at assigned clinical sites.

• Assure quality and timely submission of study-site data, including safety event reporting and follow-ups.

• Safeguard the welfare of study participants by adhering to monitoring plans, SOPs, guidelines, and regulatory requirements.

• Provide training to study-site personnel on protocols and regulatory obligations.

• Manage investigator payments in accordance with contractual commitments.

• Negotiate agreements with investigators and hospitals in collaboration with stakeholders.

• Complete expense reports following local and applicable guidelines.

• Identify, assess, and recommend new or potential investigators and sites.

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) is preferred.

• A minimum of 2 years of experience in clinically-related monitoring is required.

• Experience with on-site monitoring of investigational drug or device trials is essential.

• Current, thorough knowledge and understanding of relevant therapeutic indications related to the execution of clinical trials.

• Up-to-date knowledge of regulations governing clinical research, including ICH/GCP Guidelines and applicable laws.

• Familiarity with all facets of study monitoring, including data management, drug accountability, and documentation experience.

• Strong organizational and planning skills, with the capability to work effectively and efficiently in a fast-paced environment with multiple projects and deadlines.

• Ability to comprehend, follow, and execute processes within the assigned function.

• Excellent analytical and conceptual skills, along with interpersonal abilities and clear communication.

• Capability to resolve study-related clinical site issues with appropriate guidance and to initiate and communicate corrective actions when necessary.

• Ability to apply functional expertise and demonstrate sound judgment.

• Proven business ethics and integrity.

• Willingness to travel a minimum of 50% of the time.

• Proficient in Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.).

• Comfortable with technology and adept at using various tools/systems for daily tasks.

• Valid driver’s license and passport required.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

• Paid time off including vacation, holidays, personal days, and volunteer days.

• Employee stock purchase program.

• Wellness spending account.

• Flexible health insurance options.

• Retirement savings programs.

• Bonus plan.