FSP CRA (Level II) - Client Dedicated Romania

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

At PPD, part of Thermo Fisher Scientific, we are dedicated to meaningful work that positively impacts global health. We empower our colleagues to achieve their career goals while advancing scientific research and delivering life-changing therapies. With clinical trials conducted in over 100 countries and innovative research frameworks, we are at the forefront of laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will contribute to improved health outcomes for individuals and communities.

This is an excellent opportunity for CRAs in the life sciences sector (pharmaceutical companies, biotech companies, or CROs) to collaborate with a world-leading CRO across diverse sponsors, protocols, and therapy areas.

Essential Functions

• Site Monitoring: Conducts risk-based monitoring of investigator sites, utilizing root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures. Implements corrective and preventive actions to ensure compliance and mitigate risks.
• Data Accuracy: Ensures data integrity through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring activities.
• Investigational Product Assessment: Assesses investigational product through physical inventory checks and records review.
• Documentation: Documents observations in reports and letters within established timelines, adhering to business writing standards.
• Issue Escalation and Resolution: Expedites escalation of observed deficiencies and issues to clinical management and ensures their resolution. Maintains regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Investigator Payment: Participates in the investigator payment process.
• Team Collaboration: Shares responsibility with project team members for issue/finding resolution and conducts investigations and follow-ups as needed.
• Investigator Meetings: Participates in investigator meetings as required.
• Site Identification: Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Site Initiation: Initiates clinical trial sites in compliance with relevant procedures, protocol, regulatory, and ICH GCP obligations, providing recommendations where necessary.
• Trial Close-out: Performs trial close-out activities and retrieves trial materials.
• Essential Document Management: Ensures the completeness and availability of essential documents according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Reporting: Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems (e.g., Clinical Trial Management System) are updated according to agreed conventions.
• Project Contribution: Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas with team members.
• Process Improvement: Contributes to other project work and initiatives focused on process improvement.

Education and Experience

• University degree in a science-related field.
• Understanding of ICH-GCP, EU, and FDA requirements.
• Fluency in English.
• Valid driver's license.

Knowledge, Skills, and Abilities

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• Demonstrated ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills, including a critical mindset and in-depth investigat...