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Work From Home Clinical Research Associate II

Valesta Clinical Research Solutions - Richmond, VA

Job is located in Fort Lauderdale, FL.
• Build relationships with investigators and site staff
• Participate in Investigator and other external or internal meetings as required
• Arrange on-site visits and logistics (e.g. travel arrangements)
• Perform on site visits and generate visit/contact reports in accordance with the monitoring plan
• Perform site facilities inspection
• Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
• Responsible for the completeness and quality of the on-site files
• Respond to site issues alerted by the project team (i.e, non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
• Collect SRP documents during site visits as needed
• Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit
• Update all relevant tracking system on an on-going basis
• Code and scan Central File documents where applicable
• Ship relevant wet-ink signature documents to the Assistant or back to the site
• Monitor and maintain compliance with ICH-GCP Guidelines, local regulatory requirements, Client SOPs, and study specific procedures
• Escalate any issues that require immediate action to the CRA Coordinator or COL
• Inform responsible CRA Coordinator/COL/Manager of work status regularly
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)
Job Requirements
• To qualify, you should have at least 3-5 years of on-site clinical monitoring experience.
• • BA/BS degree
• Knowledge of the Clinical Development process
• Proven track record of demonstrating through knowledge of regional health care environment
• Experience in investigator contract management
• Experience in preparing documents for submission to IRBs/IECs and Competent Authorities
• Computer literacy (e.g. EDC, CTMS, MS office, etc.)
• Excellent verbal and written communication skills in English and local language
• Experience in participating in internal audits is preferred
• Previous involvement in protocol, CRF, or other trial-related development activities preferred
• Able to travel as needed

Valesta Clinical Research Solutions

Location: Richmond, VA