In-House CRA II

🕒 July 4

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

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

• Provide overall support to study sites and clinical project teams engaged in clinical research studies • Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements • Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools • May assist in identifying study sites by performing site feasibility and recruitment tasks • Schedules internal and external meetings as required • Prepares Investigator Site Files including distribution to study sites • Performs ongoing essential document collection and review • Organizing and maintaining site level data in the trial master file (TMF) • Perform set ups and maintain site-related data in applicable clinical systems • Acts as site contact/liaison for study and site management issues • Ensures timely and complete data entry by site in EDC • Sends email blasts/newsletters and updates to study site personnel • Assists in providing logistics support in samples management and tracking • Supports investigators in fulfilling obligations regarding local submissions • Assists in data review inclusive of site level data review • Assist with study tracking via the CTMS • Documents site and Sponsor contact and study interactions in a timely manner • Assist in remote review of the electronic Investigator Site File • Assists with Investigational Product accountability • Consults with project team members regarding study site issues • Provides quality review of the amended site level informed consent template • Follows up with sites for trial invoices

🎯 Requirements

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline • Minimum of 2 years of relevant 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 • Working knowledge of the drug development process • Ability to travel as needed

🏖️ Benefits

• (No benefits listed)