Live chat

We're Sorry..


The job you clicked on has expired or has been removed and is no longer available. The original listing can be found at the bottom of the page for your reference.

Work From Home Clinical Research Associate II

Valesta Clinical Research Solutions - Richmond, VA

Job is located in Fort Lauderdale, FL.
Role:
• 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
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