Senior In-house CRA (LATAM)
New
P
Precision Medicine GroupClinical 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 in a business, scientific, or healthcare discipline.
- Minimum 4 years of clinical trial or related industry experience.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of the drug development process.
- Demonstrated experience with CTMS, TMF, and EDC clinical systems.
- Fluency in English communication (verbal and written).
- Strong interpersonal skills and ability to work independently in a remote environment.
- Ability to focus on detail and accuracy for extended periods.
- Ability to travel as needed.
- In-depth knowledge and utilization of ICH-GCP and regulatory guidance.
Responsibilities
- Assist with investigator recruitment activities using phone scripts, questionnaires, and site materials.
- Perform site feasibility and recruitment tasks including reviewing site recruitment questionnaires.
- Prepare, distribute, and manage Investigator Site Files and site-level data in the Trial Master File (TMF).
- Maintain site-related data in clinical systems, including the Clinical Trial Management System (CTMS).
- Act as a primary site contact to address questions, manage study supplies, and escalate study issues.
- Ensure timely and complete data entry by sites in EDC or other required systems.
- Support site compliance with local regulatory, IRB, and IEC requirements.
- Provide training, mentoring, and leadership to less-experienced In-house CRA team members.
- Participate in the creation of Clinical Monitoring Plans, visit letter templates, and site start-up plans.
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