Role OverviewJoin a patient-focused clinical research team as a Sponsor Dedicated CRA II, operating remotely from Portugal. In this role, you will manage investigative sites across the study lifecycle—from qualification to close-out—ensuring adherence to protocols, regulatory requirements, and data quality standards in late-phase real-world studies, particularly within oncology.
Key Responsibilities
- Conduct and document site visits, both on-site and remotely, including qualification, initiation, monitoring, and close-out activities
- Verify informed consent procedures, data accuracy in case report forms, and source document consistency
- Assess site performance, identify risks to patient safety or data integrity, and escalate critical issues promptly
- Support electronic data capture compliance and apply query resolution methods to ensure timely data closure
- Review Investigator Site Files and align content with Trial Master File expectations
- Monitor investigational product handling, including storage, dispensing, and accountability, in line with protocol and regulations
- Collaborate with sponsor teams, medical science liaisons, and local staff to support study execution
- Train junior staff when required and contribute to audit readiness at assigned sites
- Participate in project meetings, investigator sessions, and ongoing clinical training as needed
- Use tracking systems to log observations, action items, and follow-up activities
- Advise on potential new sites based on local healthcare patterns and provider networks
Qualifications
Applicants should hold a Bachelor’s degree or equivalent in a life science or nursing field. Familiarity with ICH-GCP, pharmacovigilance, and Good Pharmacoepidemiology Practice (GPP) is essential. Experience in oncology trials is beneficial. Strong organizational, communication, and technical skills are required, along with the ability to travel up to 75% as needed.
Proficiency with clinical monitoring software, electronic data capture systems, and standard office tools is expected. Candidates must stay current with regulatory guidelines and internal processes, complete assigned training, and support compliance across all site activities.
Work Environment
This is a home-based position serving sites in Portugal, offering flexibility within a structured, agile framework. The role operates within a global, collaborative environment focused on innovation, inclusion, and real-world healthcare impact. You will work closely with cross-functional teams while maintaining autonomy in managing site relationships and compliance.
Professional Growth
The organization supports career advancement through structured training, peer recognition, and continuous learning in therapeutic and technical domains. You’ll be part of a culture that values authenticity, teamwork, and meaningful contributions to patient progress.
