Senior In-house CRA – LATAM
Posted 2hrs ago
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Job Description
Senior In-house CRA providing clinical research support for expanding operations in Mexico and LATAM region. Focused on building foundation through study site support and adherence to regulatory requirements.
Responsibilities:
- Provides overall support to study sites and clinical project teams engaged in clinical research studies
- Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements
- Acts as a point of contact for study sites
- Schedules internal and external meetings as required
- Prepares Investigator Site Files including distribution to study sites
- Performs ongoing essential document collection and review, maintenance, and close-out activities
- Assists with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials
- Ensures timely and complete data entry by site in EDC or any other system that requires data entry
- May serve as an Independent Essential Document Reviewer post-SIV by supporting on-site visit activities
Requirements:
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- 4 years of clinical trial or related experience
- High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
- Fluency in English communication, verbally and in writing
- In-depth knowledge of the drug development process
- Experienced with utilizing CTMS, TMF, and EDC systems
- Ability to travel as needed
Benefits:
- Health insurance
- Customer service demeanor; demonstrate flexibility and teamwork
- Professional development opportunities



















