Senior Clinical Research Associate – Remote Site Lead

Parexel; Honolulu (HI); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel FSP in the US is seeking a Senior Clinical Research Associate to lead site monitoring and management for assigned investigator sites. The Sr. CRA ensures patient safety, data integrity, and compliance with GCP and client standards while coordinating with the SCP and study team.

The role requires strong monitoring experience, Oncology exposure preferred, and willingness to travel 60-80% within the region. English proficiency and a life sciences background are essential.

Qualifications

• Extensive knowledge of clinical trial methodologies and GCP standards.
• Experience with site monitoring and management in clinical trials.
• Understanding of regulatory requirements across US jurisdictions.

Responsibilities

• Oversee site monitoring and conduct in accordance with SMP and GCP.
• Manage investigator site relationships to ensure trial delivery and quality.
• Coordinate with SCP and study team for site setup, activation, and close-out.
• Monitor data queries, SAE reporting, and TMF documentation within timelines.
• Support enrollment and site activation, providing guidance on protocol interpretation.
• Travel as required to investigator sites and meetings.

Skills

Clinical trial methodology

ICH/GCP knowledge

FDA regulations

English fluency

Relationship management

Site monitoring

Study data review

Education

Bachelor’s degree in life sciences or equivalent

Job description

Parexel FSP in the US is seeking a Senior Clinical Research Associate to lead site monitoring and management for assigned investigator sites. The Sr. CRA ensures patient safety, data integrity, and compliance with GCP and client standards while coordinating with the SCP and study team.

The role requires strong monitoring experience, Oncology exposure preferred, and willingness to travel 60-80% within the region. English proficiency and a life sciences background are essential.