Senior Clinical Research Associate, Contractor
AIXIAL GROUP
contract
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
Tech Stack
About the role
- The Sr. CRA is responsible for site management and monitoring activities associated with clinical studies
- Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs
- Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures
- Complete and submit timely site visit reports per the monitoring plan/SOPs
- Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting
- Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff
- Discuss, review, and document patient recruitment strategies with assigned sites
- Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan
Requirements
- Bachelor’s (or equivalent) degree in science, medical health, or related discipline or equivalent relevant experience
- A minimum five years of clinical monitoring experience in the Pharmaceutical/CRO industry
- Good clinical and therapeutic knowledge with understanding of medical and pharmaceutical industry terminology
- Excellent oral and written communication skills
- Strong knowledge of ICH GCP guidelines and applicable regulations
Benefits
- Fully remote 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords
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Hard Skills & Tools
clinical monitoringsite managementsite qualificationsite initiationinterim monitoringclose-out visitsstudy documentationdrug accountabilitysafety reportingpatient recruitment strategies
Soft Skills
communication skillsrelationship buildingorganizational skills
Certifications
Bachelor’s degreeICH GCP certification