Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a leader in supporting pharmaceutical companies and biotechs in clinical trials. As a Clinical Research Associate II, you will perform and coordinate all aspects of clinical monitoring and site management, ensuring compliance with protocols and regulations.

Responsibilities

• 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 (i.e., FSO, FSP, Government, etc.)
• Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability
• 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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