Principal In-house CRA (LATAM)
New
P
Precision Medicine GroupClinical Research
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
- Project ManagementMicrosoft Office
Requirements
- Bachelor's degree or international equivalent in a business, scientific, or healthcare discipline.
- Minimum 6 years of clinical trial or related professional experience.
- In-depth knowledge of the drug development process and ICH-GCP guidelines.
- Extensive experience utilizing CTMS, TMF, and EDC systems.
- High proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Strong interpersonal, leadership, and communication skills.
- Ability to work independently and as part of a team.
- Fluency in English (verbal and written).
- Ability to travel as needed.
- Customer service demeanor with high attention to detail.
Responsibilities
- Manage and perform investigator recruitment activities in partnership with the study team.
- Prepare, distribute, and maintain Investigator Site Files and trial master file (TMF) documentation.
- Utilize and maintain site-related data in Clinical Trial Management Systems (CTMS) and EDC systems.
- Act as a site contact/liaison to address study management issues and site queries.
- Support investigators with regulatory submissions, IRB/IEC requirements, and samples management.
- Provide leadership, training, and coaching to the in-house CRA team.
- Develop and maintain clinical project documents, including Clinical Monitoring Plans and Site Start-up Plans.
- Consult on risk management strategies and provide oversight for project delivery.
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