Sr. Clinical Research Associate (Romania)
Core
Independently performs, coordinates, and oversees all aspects of clinical site monitoring services, assessing protocol and regulatory compliance for Alimentiv and sponsor clinical studies.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical study data integrity and regulatory compliance for pharmaceutical/medical device trials
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical site monitoring, protocol compliance, ICH-GCP guidelines, data query resolution, clinical supply coordination, site recruitment and setup, TMF management, audit/inspection participation, mentoring junior CRAs
Preferred skills
Sr.CRA and/or ACRP Certification, Phase I–IV clinical trial experience, Health Sciences/Life Sciences/Pharmacy/Nursing degree
Technologies
Medidata Rave, Oracle InForm, IRT, eTMF, CTMS, Microsoft Office Suite
Responsibilities
Conduct onsite and remote site monitoring and close-out visits; ensure data consistency between study systems and source documents; coordinate shipment of investigational products and supplies; identify and qualify investigational sites; mentor CRA I and II staff; participate in audits and inspections; optimize patient recruitment; review ISF and TMF for accuracy and completeness.
Seniority
Senior, hands-on IC
