Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About Thermo Fisher Scientific

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life — enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve career goals while advancing science through research, development, and delivery of life-changing therapies.

Through our PPD clinical research portfolio, we partner with clients in more than 100 countries to deliver flexible, high-quality clinical trial services. Your commitment to quality, accuracy, and compliance will help ensure the success of our partnerships and improve health outcomes that people and communities depend on — now and in the future.

Summarized Purpose

The CRA I (FSP model) is responsible for supporting the monitoring and management of investigator sites to ensure clinical trials are conducted according to the study protocol, ICH-GCP, sponsor SOPs, and applicable regulatory requirements. Under supervision, this role performs on-site and remote monitoring activities, assists with site management tasks, and contributes to data quality, subject safety, and compliance across assigned studies for a specific client.

Key Responsibilities

• Conduct monitoring visits (on-site and remote) as assigned, in accordance with the client’s monitoring plan and applicable SOPs.

• Verify that clinical data are accurate, complete, and verifiable from source documents (SDR/SDV).

• Support site initiation, routine monitoring, and close-out visits under supervision.

• Ensure timely collection and review of essential documents in accordance with ICH-GCP and regulatory requirements.

• Maintain regular communication with site personnel to ensure protocol adherence, timely data entry, and resolution of issues.

• Assist in tracking site performance metrics and follow up on action items to maintain study compliance.

• Support submission activities to regulatory authorities (e.g., HSA) and institutional review boards (IRB/IEC) as required.

• Accurately document observations in visit reports and correspondence within required timelines.

• Ensure timely completion of administrative tasks such as training, timesheets, and expense reporting.

• Collaborate effectively with project team members and client representatives to ensure consistent study delivery and quality outcomes.

• Participate in required study-specific and corporate training to continuously develop monitoring expertise.

Education and Experience

• Bachelor’s degree in life sciences, nursing, pharmacy, or equivalent field.

• Prior experience in clinical research (e.g., as CTA, CRC, or CRA trainee) preferred.

• Foundational understanding of ICH-GCP, clinical trial operations, and local regulatory requirements.

• Excellent organizational, communication, and interpersonal skills.

• Ability to work effectively under supervision and develop independent monitoring skills over time.