Sr Clinical Research Associate (Serbia)
Core
Senior Clinical Research Associate managing clinical site monitoring and site management activities across Serbia and Croatia for gastrointestinal disease therapies.
Role type
Senior individual contributor Clinical Research Associate
Builds
Clinical trials for gastrointestinal disease therapies
Domain
Clinical research / Gastroenterology
Required skills
Clinical site monitoring, ICH-GCP knowledge, regulatory compliance, data integrity review, site activation and recruitment, essential study documentation management, mentoring junior CRAs
Preferred skills
Master's degree, 7-9 years experience, Phase I-IV trial experience, Medidata Rave or Oracle InForm proficiency, experience mentoring junior CRAs
Technologies
EDC, IRT, eTMF, CTMS, Medidata Rave, Oracle InForm
Responsibilities
Conduct onsite and remote monitoring visits (qualification, initiation, monitoring, close-out), ensure site compliance with protocols and regulations, serve as primary point of contact for site issues, review clinical trial data and source documentation, support site selection and recruitment, train sites on protocols and processes, maintain essential study documentation (ISF, TMF), participate in audits and meetings, mentor junior CRAs
Seniority
Senior, hands-on IC with mentorship responsibilities
