About the Clinical Research Associate Role

Thermo Fisher Scientific, Inc. is seeking a Clinical Research Associate (CRA) I/II to join their FSP team. This is a full-time position. In this role, you will be responsible for coordinating and executing all aspects of clinical monitoring and site management processes across various sponsors and monitoring environments. You will act as a specialist in site processes, ensuring trials adhere to approved protocols, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to safeguard subject rights, well-being, and data integrity. The role requires a proactive approach to ensure audit readiness and foster collaborative relationships with investigational sites.

Key Responsibilities

• Conduct site monitoring using a risk-based approach, applying root cause analysis and critical thinking to identify and resolve process failures and mitigate risks.
• Ensure data accuracy through Source Data Review (SDR) and Source Data Verification (SDV) via on-site and remote monitoring.
• Assess investigational products through physical inventory checks and record reviews.
• Document observations and findings in reports and letters according to approved business writing standards.
• Expeditiously escalate observed deficiencies and issues to clinical management and follow them through to resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Execute monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Collaborate with project team members on issue and finding resolution.
• Investigate and follow up on findings as applicable.
• Participate in investigator meetings as required.
• Identify potential investigators in collaboration with the client to ensure site acceptability.
• Initiate clinical trial sites in compliance with relevant procedures, protocol, and regulatory obligations, making recommendations as needed.
• Perform trial close-out activities and retrieve trial materials.
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress reports to the Clinical Team Manager (CTM).
• Ensure study systems, such as the Clinical Trial Management System (CTMS), are updated according to study conventions.
• Facilitate effective communication between investigative sites, the client, and the project team.
• Respond to company, client, and regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, in a timely manner.
• Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas for process improvement.

Qualifications and Experience

Candidates should possess a Bachelor's degree in a life science-related field, or a Registered Nursing certification, or an equivalent relevant academic or vocational qualification. A valid driver's license is required where applicable. The role requires 0-1 years of experience. Proven clinical monitoring skills are essential, along with a demonstrated understanding of medical/therapeutic area knowledge and medical terminology.

Required Skills and Competencies

• 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, in-depth investigation for root cause analysis, and problem-solving abilities.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Ability to maintain customer focus through effective listening, attention to detail, and identifying underlying customer issues.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in various scenarios.
• Ability to work independently or as part of a team.
• Good computer skills, including solid knowledge of Microsoft Office and the ability to learn new software.
• Good English language and grammar skills.
• Good presentation skills.

Work Environment and Travel

Work may be performed in an office, laboratory, clinical, or home office environment. This role involves frequent travel to site locations, generally estimated at 60-80%, with potential for extended overnight stays. Exposure to electrical office equipment is expected. There may be exposure to biological fluids with potential for infectious organisms, requiring the use of personal protective equipment such as protective eyewear, garments, and gloves. Occasional exposure to fluctuating or extreme temperatures may occur.