Senior In-house CRA – LATAM
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Job Description
Senior In-house CRA providing essential support to study sites and clinical teams in Latin America. Ensuring compliance with ICH/GCP guidelines and maintaining effective communication across teams.
Responsibilities:
- Provides overall support to study sites and clinical project teams engaged in clinical research studies
- Acts as a point of contact for study sites
- Works independently in providing support to CRA and sites
- Assists with investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for evaluating investigative 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
- Acts as site contact/liaison for study and site management issues including addressing questions
- Ensures timely and complete data entry by site in EDC or other systems
- Sends email blasts/newsletter to study site personnel
- Supports investigators in fulfilling obligations regarding local submissions
- Assists in data review inclusive of site level data review
- Documents site and Sponsor contact and study interactions in a timely and professional manner
- Provides training and mentoring to less-experienced team members
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)
- Customer service demeanor; demonstrate flexibility and teamwork
- Ability to focus on detail for extended periods of time, high attention to accuracy
- 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
- 401(k) matching
- Flexible work arrangements
- Paid time off
- Professional development opportunities
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