Work Schedule

Environmental Conditions

Job Description

Performs and coordinates different 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.

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.

Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.

Valid driver's license.