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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