Senior Clinical Research Associate

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

📋 Description

• Conduct and document onsite and remote monitoring as well as close-out visits independently.

• Ensure adherence to protocols, regulatory standards, SOPs, ICH-GCP, and study processes.

• Act as the main point of contact between the sponsor/Alimentiv and the investigative sites.

• Review source documents and study-system data to ensure consistency and compliance.

• Monitor, resolve, and escalate any data queries and site-related issues.

• Oversee the shipment of investigational products, laboratory supplies, ePROs, and study documents.

• Provide training for site staff on protocols, study plans, systems, and ICH-GCP guidelines.

• Examine ISF and TMF for accuracy, timeliness, and completeness.

• Serve as the primary contact for any questions or concerns from the investigational sites.

• Assist in site activation, qualification, initiation, recruitment, and achieving project milestones.

• Support regulatory and start-up teams with site documentation, localization, and translation tasks.

• Participate in study meetings, investigator meetings, audits, and inspections.

• Mentor CRA I and II and conduct CRA assessments or co-monitoring visits.

• Contribute to hiring interviews, process enhancements, and the development of best practices.

⛳️ Requirements

• 4–6 years of relevant experience.

• (Honors) Bachelor’s degree.

• Proficient in both written and spoken English and Spanish.

• Comprehensive knowledge of ICH-GCP and local regulatory standards.

• Skilled in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.

• Willingness to travel up to 40–60%, based on project assignments and site locations.

• Strong interpersonal and problem-solving abilities; capable of working independently and within cross-functional teams.

• Excellent communication and organizational skills, with a keen attention to detail and a sense of urgency.

• Valid driver's license required.

• A combination of education and experience equivalent to the above may also be considered.

🏝️ Benefits

• Flexible home-based work arrangement.

• Frequent travel is necessary.

• Opportunities for professional mentoring and development through CRA I and II mentorship.

• Involvement in process improvement initiatives and the creation of best practices.