Remote CRA II – Site Monitoring & Study Oversight

Parexel; Trenton (NJ); Remote; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Clinical Research Associate in the United States to act as the primary site contact and site manager across all study phases. You will build strong site relationships, oversee monitoring visits and ensure adherence to protocol, regulatory standards and Sponsor requirements.

The role requires effective communication, robust knowledge of GCP/ICH guidelines, and the ability to work independently in a fast-paced, matrix environment.

Qualifications

• Bachelor’s degree in science; strong emphasis in biology or related field.
• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
• Knowledge of ICH-GCPs and country-specific clinical research laws/guidelines.

Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs site monitoring activities in compliance with ICH-GCPs, Sponsor SOPs, local law and protocol.
• Gains understanding of the study protocol and related procedures.
• Coordinates with sponsor roles to achieve Site Ready and supports site selection/validation.
• Performs remote and on-site monitoring ensuring data quality and patient safety.
• Maintains information in CTMS/eTMF and other systems per timelines.

Skills

Site management

Communication

GCP/ICH knowledge

Documentation

Data analysis

Problem solving

MS Office

Independent judgement

Education

Bachelor’s degree in science

Tools

MS Office

Electronic Trial Master File (eTMF)

Job description

Parexel is seeking a Clinical Research Associate in the United States to act as the primary site contact and site manager across all study phases. You will build strong site relationships, oversee monitoring visits and ensure adherence to protocol, regulatory standards and Sponsor requirements.

The role requires effective communication, robust knowledge of GCP/ICH guidelines, and the ability to work independently in a fast-paced, matrix environment.