Senior Clinical Research Associate

• Independently conduct and document onsite and remote site monitoring and close-out visits
• Ensure protocol, regulatory, SOP, ICH-GCP, and study-process compliance
• Serve as primary liaison between the sponsor/Alimentiv and investigative sites
• Review source documents and study-system data for consistency and compliance
• Monitor, resolve, and escalate data queries and site issues
• Coordinate shipment of investigational products, laboratory supplies, ePROs, and study documents
• Train site staff on protocols, study plans, systems, and ICH-GCP
• Review ISF and TMF for accuracy, timeliness, and completeness
• Act as primary contact for investigational-site questions and issues
• Support site activation, qualification, initiation, recruitment, and project milestones
• Support regulatory and start-up teams with site documents, localization, and translation
• Participate in study meetings, investigator meetings, audits, and inspections
• Mentor CRA I and II and perform CRA assessment or co-monitoring visits
• Contribute to hiring interviews, process improvements, and best-practice development

• 4–6 years of related experience
• (Honors) Bachelor’s degree
• Fluent in written and verbal English and Spanish
• Thorough knowledge of ICH-GCP and local regulatory requirements
• Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite
• Ability to travel up to 40–60%, depending on project assignment and geographic location of sites
• Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams
• Great communication and organizational skills, detailed orientation and sense of urgency
• Holder of a valid driver’s license
• Equivalent combination of education and experience may be considered

• Home-based work arrangement
• Regular travel required
• Potential professional mentoring and development through CRA I and II mentorship
• Participation in process improvement initiatives and development of best practices