Clinician – CRA

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate clinical monitoring and site management activities. • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs. • Ensure audit readiness and develop collaborative relationships with investigational sites. • Monitor investigator sites using a risk-based monitoring approach. • Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions. • Ensure data accuracy through source document review, source data verification, and case report form review. • Assess investigational product inventory and records. • Document observations in reports and letters and escalate deficiencies and issues to clinical management. • Maintain contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording. • Conduct monitoring tasks according to the approved monitoring plan. • Participate in investigator payments and investigator meetings. • Help identify potential investigators and initiate clinical trial sites according to relevant procedures. • Perform trial close-out and retrieval of trial materials. • Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations. • Conduct on-site file reviews as specified by the project. • Provide trial status tracking and progress updates. • Maintain complete and accurate clinical trial systems. • Facilitate communication between investigative sites, the client company, and internal project teams. • Respond to company, client, and regulatory requirements, audits, and inspections. • Complete administrative tasks such as expense reports and timesheets. • Assist with project publications/tools and contribute to process improvement initiatives.

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification or equivalent relevant formal academic/vocational qualification. • At least 3 years of comprehensive clinician experience in a healthcare environment transferable to clinical research. • Ability to work independently or in a team. • Good organizational skills and strong attention to detail. • Proven ability to manage multiple tasks efficiently and effectively. • Ability to analyze project-specific data and systems for accuracy and efficiency. • Strong customer focus. • Flexibility to reprioritize workload for changing project timelines. • Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents. • Fluency in English and local languages. • Good computer skills and proficiency in MS Office, including Word, Excel, and PowerPoint. • Ability to learn and master clinical trial database systems. • Self-motivated with a positive attitude and good interpersonal skills.

🏖️ Benefits

• Resources needed to achieve individual career goals • Accessibility service and reasonable accommodation for job seekers with disabilities • Equal employment opportunity and non-discrimination