In-House CRA II – Mexico
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Job Description
In-house CRA II providing overall support to clinical study sites engaged in research studies. Seeking experienced professional to help build a new regional function in LATAM.
Responsibilities:
- Provide overall support to study sites and clinical project teams engaged in clinical research studies
- Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH), Good Clinical Practice (GCP), and country/region-specific regulations)
- Act as point of contact for study sites
- Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites
- May assist in identifying study sites by performing site feasibility and recruitment tasks
- Schedule internal and external meetings as required
- Prepare Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required
- Perform ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data
- Ensure timely and complete data entry by site in EDC or any other system that requires data entry
- Document site and Sponsor contact and study interactions in a timely and professional manner
Requirements:
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- Minimum of 2 years of relevant 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
- Working knowledge of the drug development process
- Ability to travel as needed
Benefits:
- Health insurance
- Retirement plans
- Paid time off
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