Senior Clinical Research Associate (level dependent on experience)

Accountabilities

• Oversight of clinical site management activities
• Ensuring studies are conducted according to protocols, regulatory requirements, and quality standards
• Strong attention to detail, effective stakeholder communication, and the ability to manage multiple study activities throughout the clinical trial lifecycle
• Serve as the primary contact for assigned clinical study sites
• Conduct monitoring visits, including pre-study visits, site initiation visits, interim monitoring visits, and close-out visits, ensuring compliance with monitoring plans, SOPs, and ICH-GCP guidelines
• Support study start-up activities, including feasibility assessments, site selection, regulatory documentation, and site activation processes
• Review, collect, and maintain essential regulatory documents, investigator site files, and trial master files according to applicable procedures
• Maintain patient enrollment activities and support site-specific strategies to improve recruitment and retention
• Ensure proper handling, storage, accountability, and documentation of investigational products and trial materials
• Perform remote monitoring activities and use clinical trial systems and reports to track study progress, data quality, documentation status, and compliance
• Identify site performance issues, implement corrective actions, and escalate risks when necessary
• Collaborate with Clinical Data Management teams to support data review and cleaning activities
• Participate in investigator meetings, client meetings, project team discussions, and study-specific training sessions
• Support the preparation and review of clinical study documents, including case report forms, monitoring plans, patient information materials, and informed consent documentation
• Afford regulatory and ethics submission activities when required, ensuring timely approvals and communication with relevant stakeholders
• Provide updates on site status, enrollment progress, risks, and milestones to clinical project leadership
• Support contract discussions, investigator payments, and site payment tracking when applicable

Requirements

• Minimum of 1 year of clinical trial monitoring experience or equivalent relevant experience
• Bachelor’s degree or higher in a healthcare-related discipline such as nursing, pharmacy, health sciences, or natural sciences, or equivalent clinical experience
• Registered Nurse (RN) qualification with relevant clinical experience, or equivalent professional background considered
• Previous experience conducting clinical research studies within a hospital, pharmaceutical company, or Contract Research Organization (CRO) environment
• Demonstrated experience performing site monitoring activities, preferably with at least one year of on-site monitoring experience
• Strong understanding of clinical research processes, ICH-GCP guidelines, regulatory requirements, and SOP compliance
• Excellent organizational skills with the ability to manage multiple priorities, timelines, and study requirements
• Strong written and verbal communication skills with the ability to collaborate effectively with investigators, sponsors, and internal teams
• Ability to identify issues, apply sound judgment, and implement solutions in a clinical research environment
• Proficiency with clinical trial systems, documentation tools, and standard office applications
• Commitment to maintaining high-quality standards and protecting patient safety throughout the research process

Benefits

• Competitive compensation package, including eligibility for a sign-on bonus of up to $10,000
• Fully remote work opportunity with flexibility and support for work-life balance
• Comprehensive health benefits and vacation packages
• Paid parental leave and programs supporting employee well-being
• Structured mentoring programs and leadership development opportunities
• Tuition reimbursement and access to ongoing training resources
• Opportunity to contribute to research programs that help bring life-changing therapies to patients
• Supportive global team culture focused on collaboration, innovation, and professional growth
• Employee engagement initiatives and community programs promoting positive impact