Clinical Research Associate II

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

📋 Description

• Take proactive measures to address clinical site issues related to studies, and initiate, recommend, and communicate corrective actions.

• Oversee activities at clinical investigative sites to ensure successful execution of protocols.

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

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

• Supervise site personnel activities, motivating and influencing them to achieve study objectives.

• Proactively manage sites and implement action plans to maintain compliance.

• Ensure readiness for regulatory inspections at assigned clinical sites.

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

• Safeguard study subject safety and protection by adhering to monitoring plans, SOPs, guidelines, and regulations.

• Provide training for study site personnel on protocols and regulatory requirements.

• Manage investigator payments in accordance with executed contractual obligations.

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

• Complete expense reports following the relevant guidelines.

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

⛳️ Requirements

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

• At least 2 years of experience in clinically-related monitoring.

• Required experience in on-site monitoring of investigational drug or device trials.

• Current in-depth knowledge and understanding of relevant therapeutic indications as they pertain to clinical trial conduct.

• Strong familiarity with the regulations governing clinical research, including ICH/GCP Guidelines and applicable regulations.

• Comprehensive understanding of all aspects of study monitoring, including data management, drug accountability, and documentation experience.

• Excellent planning and organizational skills with the ability to work effectively in a fast-paced environment with competing projects and deadlines.

• Ability to comprehend and adhere to work processes within the assigned function.

• Strong analytical and conceptual skills, interpersonal abilities, and effective communication skills.

• Capability to address study-related clinical site issues and initiate and communicate corrective actions as needed.

• Ability to apply functional expertise and exercise sound judgment.

• Proven business ethics and integrity.

• A minimum of 50% travel is required.

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

• Comfortable with technology and various tools/systems utilized for daily tasks.

• Valid driver’s license and passport are required.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

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

• Employee stock purchase options.

• Wellness spending account.

• Flexible health insurance plans.

• Retirement savings programs.

• Bonus plan.

• Options for remote work.