Sr Cra
3 semanas atrás
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 monitoring
environments (i.e. 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
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
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
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