In-House CRA II – Mexico

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Provide comprehensive support to clinical project teams and study sites involved in clinical research studies.

• Comply with relevant protocols, standard operating procedures (SOPs), and all applicable guidelines and regulatory standards (e.g., International Council for Harmonization (ICH), Good Clinical Practice (GCP), and country/region-specific regulations).

• Serve as the primary contact for study sites.

• Assist with investigator recruitment efforts by utilizing phone scripts, questionnaires, study site materials, and various tools for evaluating investigative sites.

• May aid in identifying study sites through site feasibility and recruitment activities.

• Organize and schedule both internal and external meetings as necessary.

• Prepare Investigator Site Files, including their distribution to study sites (either electronically or physically) and coordinate with shipping vendors as needed.

• Conduct ongoing collection, review, maintenance, and close-out activities of essential documents, ensuring proper organization of site-level data.

• Ensure timely and accurate data entry by site personnel in EDC or any other required data entry systems.

• Document interactions with study sites and the Sponsor in a timely and professional manner.

⛳️ Requirements

• Bachelor's degree or international equivalent, or a comparable mix of education and experience, preferably in a business, scientific, or healthcare-related field.

• At least 2 years of relevant experience.

• Strong proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• Customer service-oriented with a demonstrated ability to be flexible and work as part of a team.

• Capability to maintain a high level of attention to detail and accuracy over extended periods.

• Excellent communication skills in English, both verbal and written.

• Familiarity with the drug development process.

• Willingness to travel as required.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.