Clinical Research Associate (CRA) - Law 68/99 Art. 18
Core
Conduct on-site clinical monitoring visits at research sites to ensure protocol compliance, data accuracy, and regulatory adherence for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial monitoring, GCP compliance, regulatory document review, adverse event verification, site qualification, source data verification, patient recruitment assessment, CRA certification
Preferred skills
Master's degree in health-related field, Microsoft Office proficiency, strong communication and presentation skills
Technologies
Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Verify subject eligibility; Review adverse events and concomitant medications; Assess patient recruitment and retention; Complete monitoring reports and follow-up letters.
