Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global leader in clinical research, seeking a Clinical Research Associate II to make an impact in advancing innovative therapies. The role involves performing clinical monitoring and site management, ensuring compliance with protocols and regulations while fostering relationships with investigational sites.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
• Manage procedures and guidelines from different sponsors and/or monitoring environments
• Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs
• Ensure audit readiness and develop collaborative relationships with investigational sites

Skills

• Must be bilingual (English & Spanish) and live in either the Southeast region of the US or West region of the US
• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship
• Valid driver's license where applicable
• 1-2 years of traveling on-site monitoring experience is required
• Therapeutic experience in at least one of the following areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary
• Candidates must live within 60 miles of the nearest major airport
• Up to 80% travel is expected
• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, including a drug screening
• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• 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 the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

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