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Sr CRA - São Paulo, Brasil - Thermo Fisher Scientific
Descrição
Performs and coordinates all aspects of the clinical monitoring and site management process. Conductsremote or on-site visits to assess protocol and regulatory compliance and manages required
documentation. Manages procedures and guidelines from different sponsors and/or monitoring
environments ( FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring 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. Ensures audit readiness. Develops
collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role
are outlined in the task matrix.
Qualifications:
Education and Experience:
Bachelor's degree in a life sciences 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
2+ years as a clinical research monitor).
Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
● 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, including but not limited to: critical mindset, in-depth
investigation for appropriate root cause analysis and problem solving
● Ability to manages Risk Based Monitoring concepts and processes
● Effective 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
● Effective interpersonal skills
● Strong attention to detail
● Effective organizational and time management skills
● Ability to remain flexibile and adaptable in a wide range of scenarios
● Ability to work in a team or independently as required
● Good computer skills:
proficient knowledge of Microsoft Office and the ability to learn appropriate
software
● Good English language and grammar skills
● Good presentation skills
