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Clinical Research Associate II
Precision Medicine GroupClinical Research Associate II managing clinical studies at investigative sites for a leading CRO. Ensure compliance with protocols, regulations and standards in a flexible environment.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring and managing clinical studies in compliance with protocols, SOPs, and ICH-GCP standards, with a focus on effective coordination of study activities and regulatory submissions. Strong background in the pharmaceutical industry, particularly in oncology and early phase studies, is advantageous.
Highest-signal resume keywords
Clinical Study MonitoringCRA ExperienceOncology ExperienceRegulatory SubmissionsICH-GCP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ManagementProtocol AdherenceSOP ComplianceRegulatory KnowledgeData Reporting
Soft Skills
CommunicationCoordinationProblem-Solving
Industry Keywords
CROPharmaceutical IndustryEarly Phase StudiesInvestigator IdentificationDomestic Travel
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- 4-year college degree or equivalent experience
- Candidates should ideally have more than 1 years CRA experience within the CRO or pharmaceutical industry
- Oncology experience, early phase experience desirable although not essential
- 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
Benefits
Comp & perks- flexible working arrangements
- professional development opportunities