Join our Talent Pool - Sr Clinical Research Associate ( Croatia)
Core
Senior Clinical Research Associate managing clinical site monitoring and site management activities across Croatia, Serbia, and Bosnia 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 compliance, site management, clinical trial data review, site activation and recruitment, essential study documentation maintenance, audit and inspection participation, mentoring junior CRAs
Preferred skills
Master's degree, 7-9 years experience, Phase I-IV trial experience, Medidata Rave or Oracle InForm experience, mentoring experience
Technologies
EDC, IRT, eTMF, CTMS, Medidata Rave, Oracle InForm
Responsibilities
Conduct onsite and remote monitoring activities including site qualification, initiation, monitoring and close-out visits. Ensure investigative sites comply with study protocols, ICH-GCP, and local regulations. Serve as primary point of contact for assigned sites managing issues and protocol deviations. Review clinical trial data and source documentation for accuracy and compliance. Support site selection, activation, and recruitment activities. Maintain oversight of essential study documentation including ISF and TMF. Provide mentoring and support to junior CRA colleagues.
Seniority
Senior, hands-on IC