In-House CRA II

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 requirements.

• Assist in the recruitment of investigators using phone scripts, questionnaires, study site materials, and various tools.

• May help in identifying study sites by conducting site feasibility and recruitment tasks.

• Schedule internal and external meetings as necessary.

• Prepare Investigator Site Files, including their distribution to study sites.

• Conduct ongoing collection and review of essential documents.

• Organize and maintain site-level data within the trial master file (TMF).

• Set up and maintain site-related data in relevant clinical systems.

• Serve as the point of contact/liaison for study and site management issues.

• Ensure timely and accurate data entry by the site in the electronic data capture (EDC) system.

• Distribute email blasts, newsletters, and updates to study site personnel.

• Provide logistical support for sample management and tracking.

• Assist investigators in meeting their obligations concerning local submissions.

• Aid in the review of data, including site-level data analysis.

• Assist with study tracking through the clinical trial management system (CTMS).

• Document interactions between site and Sponsor, as well as study-related communications, promptly.

• Assist in the remote review of the electronic Investigator Site File.

• Aid in the accountability of Investigational Product.

• Consult with project team members regarding issues related to study sites.

• Provide a quality review of the amended site-level informed consent template.

• Follow up with sites regarding trial invoices.

⛳️ Requirements

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

• A minimum of 2 years of relevant experience.

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

• Strong customer service skills; ability to demonstrate flexibility and teamwork.

• Capability to maintain a focus on detail for extended durations, with a high level of accuracy.

• Fluent in English communication, both verbally and in writing.

• Familiarity with the drug development process.

• Willingness to travel as necessary.

🏝️ Benefits

• (No benefits listed)