Clinical Research Associate II — Site Lead

Parexel; California; In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Parexel seeks a Clinical Research Associate II to act as primary site contact and site manager across all study phases. You will ensure site readiness, monitor adherence to protocol, and maintain robust site relationships while safeguarding participant safety.

Responsibilities include coordinating with sponsor teams, performing visits from initiation to closeout, and maintaining regulatory documentation. Extensive travel is required, with strong collaboration across a matrix environment.

Competenze

• Minimum 2 years of direct site monitoring experience in biotech/pharma/CRO.
• Bachelor's degree with science emphasis required.
• Strong knowledge of ICH-GCP and regulatory guidelines.
• Ability to travel 65-75% of working time.

Mansioni

• Develops strong site relationships across trial phases and maintains continuity.
• Performs site monitoring in compliance with ICH-GCP, SOPs, and regulations.
• Gains understanding of the study protocol and procedures.
• Coordinates with sponsor roles to achieve Site Ready.
• Performs remote and on-site monitoring and oversight activities.
• Ensures data quality, subject safety, and timely reports.

Conoscenze

Site management

Monitoring

ICH-GCP knowledge

Communication skills

Data analysis

Time management

Travel willingness

Independent work

Formazione

Bachelor's degree in science/biology

Descrizione del lavoro

Parexel seeks a Clinical Research Associate II to act as primary site contact and site manager across all study phases. You will ensure site readiness, monitor adherence to protocol, and maintain robust site relationships while safeguarding participant safety.

Responsibilities include coordinating with sponsor teams, performing visits from initiation to closeout, and maintaining regulatory documentation. Extensive travel is required, with strong collaboration across a matrix environment.