Remote CRA II: Site Management & Monitoring

Parexel; United States; Remote; USD 75.000 - 110.000; Vollzeit

Zusammenfassung

Parexel in the United States is seeking a Clinical Research Associate II to serve as the primary site contact and site manager for assigned sites throughout all phases of a clinical study. You will monitor sites in the West or Pacific Northwest, ensure data integrity, and ensure compliance with ICH-GCP and sponsor SOPs.

The role requires 2+ years of monitoring experience, a Bachelor's degree in science, willingness to travel up to 65–75%, and strong communication skills.

Qualifikationen

• 2+ years of direct site monitoring experience in biotech/pharma/CRO
• Bachelor's degree with strong emphasis in science and/or biology
• Willingness to travel domestically and internationally up to 65–75%
• Fluent in English with excellent written and spoken communication

Aufgaben

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
• Performs site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local laws & Regulations, Protocol
• Gains an in-depth understanding of the study protocol and related procedures
• Coordinates and manages tasks with sponsor roles to achieve Site Ready
• Communicates with Investigators and site staff on protocol conduct and site performance
• Collects, reviews, and monitors regulatory documentation for study start-up, maintenance and close-out
• Maintains information in CTMS/EMF and other systems per timelines
• Performs co-monitoring visits where appropriate
• Supports audits/inspection activities as needed

Kenntnisse

Fluent English

Site management

Monitoring

Data analysis

Communication skills

IT proficiency

Ausbildung

Bachelor's degree in science/biology

Tools

MS Office

Clinical IT tools

Jobbeschreibung

Parexel in the United States is seeking a Clinical Research Associate II to serve as the primary site contact and site manager for assigned sites throughout all phases of a clinical study. You will monitor sites in the West or Pacific Northwest, ensure data integrity, and ensure compliance with ICH-GCP and sponsor SOPs.

The role requires 2+ years of monitoring experience, a Bachelor's degree in science, willingness to travel up to 65–75%, and strong communication skills.