Lead Clinical Research Associate US

Role Summary

Lead Clinical Research Associate

We are seeking an experienced and highly motivated Lead Clinical Research Associate to join our Clinical Operations team. This role requires a seasoned professional who excels in managing high-volume site portfolios across Canada, Australia, Europe and the USA. The ideal candidate will demonstrate exceptional site management skills, strong leadership capabilities, and a proven track record of delivering quality monitoring outcomes and site deliverables in complex, multi-national clinical trials.

Responsibilities

• Site Management & Monitoring: Serve as lead monitor overseeing contract CRO’s monitoring teams with a high-volume portfolio of active sites
• Conduct routine and for-cause monitoring and site visits, ensuring compliance with ICH-GCP, FDA regulations, and study protocols
• Perform comprehensive source data verification, regulatory document review, and investigational product accountability
• Identify and escalate site performance issues, implementing corrective and preventive action plans (CAPA)
• Ensure timely resolution of data queries, protocol deviations, and site-level audit findings
• Manage site initiation, activation, and close-out activities with precision and efficiency
• Attend SIV’s, Investigator Meetings, and perform onsite training and support as needed

• Leadership & Mentorship: Conduct training sessions on monitoring best practices, GCP compliance, and study-specific procedures
• Review and approve monitoring reports prepared by team members
• Serve as an escalation point for complex site issues and challenging investigator relationships
• Participate in cross-functional team meetings representing the site monitoring perspective

• Quality & Compliance: Ensure all site activities maintain the highest quality standards and regulatory compliance
• Identify potential risks to data integrity, patient safety, and study timelines
• Implement risk-based monitoring strategies to optimize site oversight
• Prepare for and support regulatory inspections and audits at clinical sites
• Maintain comprehensive and audit-ready trial master file documentation

• Study Execution: Collaborate with study teams to achieve enrollment targets and maintain study timelines
• Build and maintain strong relationships with principal investigators, site coordinators, and institutional staff
• Facilitate effective communication between sites and internal stakeholders
• Contribute to continuous process improvement initiatives within clinical operations
• Participate in site selection, feasibility assessments, and investigator meetings

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related field required
• Advanced degree (Master's, PharmD, MD) preferred
• Minimum 5-7 years of clinical monitoring experience in the pharmaceutical or biotechnology industry
• Proven track record managing high-volume site portfolios
• Extensive experience with Phase II and Phase III global clinical trials
• Demonstrated expertise in monitoring across Canada, Australia, Europe and the USA regions
• Experience in Gastrointestinal disorders and/or a nursing background strongly preferred
• Previous lead or senior CRA role with oversight responsibilities
• Expert knowledge of ICH-GCP guidelines, FDA regulations (21 CFR Parts 50, 56, 312), and EU Clinical Trial Directive
• Proficiency with electronic data capture (EDC) systems (Medidata Rave, Oracle Inform, or similar)
• Strong understanding of clinical trial processes from start-up through close-out
• Experience with CDISC standards, source data verification, and data quality management
• Competency in CTMS platforms and eTMF systems
• Exceptional organizational skills with the ability to manage multiple priorities simultaneously
• Outstanding attention to detail and commitment to data quality
• Strong problem-solving abilities and sound clinical judgment
• Excellent written and verbal communication skills in English (additional European languages a plus)
• Proven ability to work independently with minimal supervision
• Cultural sensitivity and adaptability for international travel and site interactions
• Resilience in high-pressure, fast-paced environments

Additional Attributes

• High-Volume Management: Demonstrated ability to efficiently manage and oversee 40+ active sites while maintaining quality standards
• Travel Flexibility: Willingness and ability to travel extensively (50%), including international trips of 1-2 weeks duration
• Relationship Building: Exceptional interpersonal skills to establish trust and credibility with diverse site personnel
• Proactive Leadership: Self-starter who anticipates challenges and implements solutions independently
• Technical Proficiency: Advanced computer skills, including MS Office, electronic systems, and virtual monitoring tools
• Time Management: Ability to prioritize competing demands and meet aggressive timelines
• Adaptability: Flexibility to adjust to changing study requirements, timelines, and travel schedules
• Strong analytical and problem-solving abilities
• Detail-oriented with strong organizational skills and the ability to manage multiple priorities
• Self-starter who thrives in a fast-paced, dynamic environment
• Ability to work both independently and collaboratively across teams
• Professional presentation with excellent written and verbal communication skills
• Flexible within a constantly changing environment
• Motivated and adaptable team player with the ability to prioritize and meet deadlines

Physical Requirements & Work Environment

• Extensive travel (50%) by air and ground to clinical sites internationally
• Ability to work flexible hours across multiple time zones
• Prolonged periods of sitting during flights and site visits
• Ability to lift and transport materials up to 15 pounds (study supplies, documents)
• Professional office environment and clinical site settings
• Virtual work environment when not traveling (home office setup provided)
• Must maintain a valid passport and the ability to travel internationally