Senior In-house CRA – LATAM

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• 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