Sr. Clinical Research Associate (Poland)
Core
Independently performs, coordinates, and oversees all aspects of clinical site monitoring services, assessing protocol and regulatory compliance for 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
client delivery
Required skills
Clinical site monitoring, protocol compliance, ICH-GCP guidelines, data query resolution, clinical supply coordination, site recruitment and activation, TMF management, mentoring junior CRAs
Preferred skills
Phase I–IV clinical trial experience, ACRP Certification, Health Sciences/Life Sciences/Pharmacy/Nursing degree
Technologies
Medidata Rave, Oracle InForm, IRT, eTMF, CTMS
Responsibilities
Conduct onsite and remote site monitoring and close-out visits; ensure data consistency with source documents; coordinate shipment of investigational products and supplies; support site recruitment and activation; mentor CRA I and II; participate in audits and inspections
Seniority
Senior, hands-on IC