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Clinical Research Associate, CRA
Location
United States
Posted
6 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate, CRA
Parexel
• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial • Gains an in-depth understanding of the study protocol and related procedures • Performs clinical study site management/monitoring activities in compliance with ICH/GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
Job Requirements
- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Fluent in local languages and English (verbal and written)
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Proven skills in Site Management including management of site performance and patient recruitment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyze data/metrics and act appropriately
- Current driver’s license required
Benefits
- Potential for flexible work arrangements
- Professional development opportunities
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