Senior Clinical Research Associate
ResearchEd
full-time
Posted on:
Location Type: Hybrid
Location: South Korea
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Job Level
Tech Stack
About the role
- Monitor clinical trials according to monitoring plans to achieve project goals
- Conduct or assist with site evaluations, study initiations, routine monitoring and site close-outs
- Work with the study start up team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- Perform data review activities, collaborate with data management to identify trends
- Ensure study documentation is maintained in the Investigator Study File
- Document accountability, stability and storage conditions of clinical trial materials
- Communicate with site study staff and Catalyst Clinical Research LLC clinical research personnel
- Proactively manage site issues and incorporate a root cause analysis and corrective action plan
Requirements
- University/college degree in life sciences preferred (or the equivalent of 5-6 years industry experience, or certification in a related allied health profession)
- Minimum of 5 years CRA direct monitoring experience with a sponsor company or CRO
- At least 2 years experience monitoring trials in oncology/heamatology
- Strong knowledge of FDA, MHRA or EMA regulations, as appropriate, and ICH GCP guidelines
- Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs
- Proficient with Microsoft Office Suite
- Familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial monitoringdata reviewroot cause analysiscorrective action planregulatory approvalmedical terminologyprotocol knowledgeclinical trial processregulatory requirementsSOP knowledge
Soft skills
communicationproblem-solvingproactive management
Certifications
university/college degree in life sciencescertification in allied health profession