SUMMARY:
The Clinical Research Associate (CRA) is responsible for overseeing and ensuring appropriate study conduct at sites in the United States. The CRA serves as the primary contact for sites, monitors the sites as required, and ensures that sites comply with GCP requirements and the protocol. The CRA identifies and ensures resolution of issues at sites by collaborating with the study project team.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
• Serve as primary point of contact for sites with a “customer focus” approach; build and maintain relationship with assigned sites.
• Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc.) to ensure high quality data and study conduct at sites.
• Ensure monitoring visits are performed in accordance with protocol/SOP requirements.
• Produce accurate and complete monitoring reports within SOP timelines.
• Ensure that monitoring visits are tracked, including report status and sign off.
• Coach investigators and other site personnel to comply with GCP and the protocol.
• Discuss recruitment and retention with site personnel, as required.
• Ensure sufficient on-site drug supply and reconcile drug on site, as required.
• Identify and escalate issues or concerns to the study project team as well as to other CRAs (sponsor and vendors).
• Identify, analyze problems and trends; recommend and assist in implementation of solutions across studies.
• Facilitate communication between other CRAs (sponsor and vendors) and the study project team.
• Accountable for completing all trip reports for assigned studies within 10 business days or within the time frame per the study SOP for reviewing and approving all trip reports.
• Develop training tools and training materials to support assigned studies.
• Develop study tools for sites and CRA use.
• Provide input to the Monitoring Guidelines.
QUALIFICATIONS AND BACKGROUND/EXPERIENCE REQUIREMENTS:
• BS or BA required.
• 4+ years experience as CRA in a pharmaceutical or biotechnology setting; experience as a study coordinator may be considered.
• Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs.
• Excellent command of MS Office tools and common eTMFs software packages in the industry.
• Self-motivated and able to function with little supervision.
• Highly detail-oriented.
• Excellent interpersonal skills.
• Superior communication skills, both verbal and written.
• Strong customer focus.
• Good team player.
• Able to resolve conflicts in a diplomatic manner.
• Solid problem-solving and decision-making skills.
• Ability to travel 70 – 80% of time.