Principal In-house CRA (LATAM)
New
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimePrincipal
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 6 years of clinical trial or related experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree or equivalent in a business, scientific, or healthcare discipline.
- Minimum 6 years of clinical trial or related experience.
- Extensive experience in clinical research.
- In-depth knowledge of the drug development process and ICH-GCP guidelines.
- Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
- Experienced with utilizing CTMS, TMF, and EDC systems.
- Fluency in English communication (verbal and written).
- Ability to work independently and as part of a remote team.
- Strong critical thinking and problem-solving skills.
- Ability to travel as needed.
Responsibilities
- Perform and manage investigator recruitment activities and develop study site tools.
- Conduct ongoing document collection, review, and maintenance in the Trial Master File (TMF).
- Manage site-related data in the Clinical Trial Management System (CTMS) to track study milestones.
- Act as the primary site contact for study management issues and supply logistics.
- Ensure timely data entry by sites in the Electronic Data Capture (EDC) system.
- Lead and mentor other in-house CRAs on project teams.
- Support management in developing training materials and project documentation like Clinical Monitoring Plans.
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