Clinical Research Associate II

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Performs and coordinates all aspects of the clinical monitoring and site management process • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation • Manages procedures and guidelines from different sponsors and/or supervising environments • Ensures that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs • Develops collaborative relationships with investigational sites • Ensures data accuracy through SDR, SDV and CRF review • Documents observations in reports and letters in a timely manner • Escalates observed deficiencies and issues to clinical management expeditiously • Ensures study systems are updated per agreed study conventions • Participates in investigator meetings • Initiates clinical trial sites according to relevant procedures • Ensures trial close out and retrieval of trial materials • Contributes to the project team by assisting in preparation of project publications/tools

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Ability to maintain customer focus • Strong attention to detail • Effective organizational and time management skills • Ability to remain flexible and adaptable in various scenarios • Good digital literacy • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits