FSP CRA (Level I)

Work Schedule

Environmental Conditions

Job Description

About Thermo Fisher Scientific

At Thermo Fisher Scientific youll 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 clients 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

• Bachelors 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.