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Job Description

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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.