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Clinical Research Associate II
Precision Medicine GroupClinical Research Associate II monitoring clinical studies and ensuring compliance at investigative sites. Coordinating study setup and monitoring activities for Precision Medicine Group.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring and managing clinical studies, ensuring compliance with protocols, SOPs, ICH-GCP, and applicable regulations. Proficient in coordinating study setup activities and site management within the pharmaceutical and biotech industries.
Highest-signal resume keywords
Clinical Research Associate (CRA)Site ManagementRegulatory SubmissionsICH-GCP ComplianceLife Science Degree
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study MonitoringProtocol AdherenceSOP ComplianceStudy Setup CoordinationPre-Study VisitsInitiation VisitsData ReportingInvestigative Site ManagementClinical Trial ManagementRegulatory Compliance
Industry Keywords
CROPharmaceutical IndustryBiotech IndustryClinical TrialsGood Clinical Practice
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
- You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Requirements
What you’ll need- Life science degree and / or equivalent experience
- 2 years or more as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.
- Availability for domestic travel including overnight stays, as required (international travel may be required for some senior level positions)
Benefits
Comp & perks- Competitive salary
- Excellent communication and organizational skills are essential. A team player.
- Evidence of a client focused approach
- Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
- Fluency in English and Hungarian
- oncology monitoring experience will be a plus
- Study start up activities experience.