Principal 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

• We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. • The Principal In-house CRA 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. • Acting as point of contact for study sites. • Has extensive site management experience which included experience and knowledge across different type of projects. • Responsible for providing senior oversight and act as subject matter expert in site management activities. • Acting as resource for Clinical Monitoring management team support and mentoring and developing others in the team. • Performs and manages investigator recruitment activities and assists with development of tools such as phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites in partnership with study team. • Schedules internal and external meetings as required. • Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required. • Performs ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data in the trial master file (TMF). • Assist with sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines. • Ensures timely and complete data entry by site in EDC or any other system that requires data entry. • Sends email blasts/newsletter, updates, and updated study core documents to study site personnel.

🎯 Requirements

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline • 6 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 hours • Paid time off • Remote work options