Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate overseeing clinical trial monitoring, site management, and recruitment for Alimentiv. Home-based in Portugal with regular travel to sites in Portugal and Spain.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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
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