Clinical Research Associate (CRA) - All Levels

Position Overview

• Location Type: [Not Specified]
• Employment Type: Full Time
• Work Schedule: Standard (Mon-Fri)
• Salary: [Not Specified]

A Clinical Research Associate (CRA) position within Thermo Fisher Scientific's PPD® clinical research services. This role involves performing and coordinating various aspects of clinical monitoring and site management, ensuring protocol and regulatory compliance, and managing site processes. The CRA will act as a site processes specialist, contributing to high-quality, cost-efficient clinical studies.

Requirements

• Experience as a Clinical Research Associate (all levels)
• Knowledge of ICH-GCP guidelines and applicable regulations
• Understanding of SOPs and clinical trial processes
• Ability to conduct risk-based monitoring
• Strong problem-solving and critical thinking skills
• Ability to apply root cause analysis (RCA)
• Excellent communication and interpersonal skills
• Ability to develop collaborative relationships with investigational sites
• Proficiency in documentation and report writing

Responsibilities

• Monitors investigator sites using a risk-based monitoring approach.
• Conducts remote or on-site visits to assess protocol and regulatory compliance.
• Manages required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
• Acts as a site processes specialist, ensuring trial adherence to protocol, GCP guidelines, regulations, and SOPs.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Reviews Source Data Records (SDR), Source Data Verification (SDV), and Case Report Forms (CRF).
• Performs physical inventory and records review of investigational product.
• Documents observations in reports and letters.
• Escalates observed deficiencies and issues to clinical management.
• Maintains regular contact with investigational sites.

Application Instructions

• [Not Specified - Further details on application process would be included here if available]

Company Information

• Company: Thermo Fisher Scientific
• Department: Clinical Operations, PPD® clinical research services
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Services: Provides end-to-end support for clinical trials from study start-up to monitoring through to study close-out, across commercial and government contracts.
• Clinical Trials: Conducted in 100+ countries with ongoing development of novel frameworks for clinical research.