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Senior Centralized Study Associate

hace 1 mes

Buenos Aires, Argentina Labcorp A tiempo completo

You will join an international team dedicated to support all types of clinical trials at the start up as during the course of the study.

Main tasks consist of document review:

- Review Initial Greenlight Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial
- Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
- File Informed Consent Form and Investigator Package approval documentation in TMF
- Review Start-up Plans that document the required quality of documents, client interactions etc for the ICF & Greenlight Packages following the available SOP with manager oversight
- Review of Patient recruiting material

Other study support can be
- US IRB submission
- Country ICF customization
- Essential document creation
- CTMS compliance management

**Main requirements**
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology)
- Fluent English
- Previous work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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