Senior In-house CRA (LATAM)
New
P
Precision for MedicineClinical Research
Mexico, Brazil, Argentina, Colombia, Chile, and PeruFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 4 years of clinical trial or related experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree or international equivalent, ideally in a business, scientific, or healthcare discipline.
- Minimum of 4 years of clinical trial or related experience.
- High proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of the drug development process and regulatory requirements.
- Strong knowledge and experience in applying ICH-GCP guidelines.
- Experienced with utilizing CTMS, TMF, and EDC clinical systems.
- Fluency in English communication, verbally and in writing.
- Ability to travel as needed.
- Demonstrated ability to work independently and as part of a team.
- Strong organizational, time management, and critical thinking skills.
- Customer service orientation with flexibility and attention to detail.
Responsibilities
- Assist with investigator recruitment activities, including site feasibility and recruitment tasks.
- Prepare and distribute Investigator Site Files (ISF) to study sites.
- Perform ongoing essential document collection, review, and maintenance in the Trial Master File (TMF).
- Maintain site-related data in the Clinical Trial Management System (CTMS) to ensure accurate tracking.
- Act as a primary contact for study sites to manage study issues, supplies, and remote monitoring tasks.
- Facilitate data entry oversight and assist in data review for database closure and freezing.
- Provide training and mentoring to junior team members and act as a lead on projects.
- Participate in the creation of clinical project documents such as Monitoring Visit Letters and Site Start-up Plans.
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