Senior In-house CRA – LATAM

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Provides overall support to study sites and clinical project teams engaged in clinical research studies • Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements • Acts as a point of contact for study 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 • Assists with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials • Ensures timely and complete data entry by site in EDC or any other system that requires data entry • May serve as an Independent Essential Document Reviewer post-SIV by supporting on-site visit activities

🎯 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) • 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 • Customer service demeanor; demonstrate flexibility and teamwork • Professional development opportunities