Freelance Senior Clinical Research Associate

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Function operationally as a member of a Project Team during clinical study conduct • Initiate, monitor on-site and remotely, and close out study sites • Provide unmasked CRA support, including investigational product accountability and oversight of unblinded site activities • Monitor clinical trials according to SOPs, GCP, ICH guidelines, and applicable regulations • Perform monitoring activities to assess subject safety, data integrity, and quality • Verify informed consent procedures and protocol compliance • Review CRFs and source documentation for validity and accuracy • Report monitoring visit actions, findings, and corrective and preventive actions • Communicate site issues and required action items • Deliver site documents to the eTMF or paper TMF • Verify Investigator Site File maintenance • Update CTMS and other project systems with accurate site information • Participate in audits and inspections, including preparation and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Assist Clinical Research or Project Managers with project tracking, monitoring plans, report review, and CRA resource management • Perform Assessment Site Visits when requested • Mentor CRAs and develop therapeutic-area training when needed • Participate in capabilities presentations

🎯 Requirements

• Bachelor’s Degree, preferably in life science or nursing, or equivalent • More than 5 years of independent on-site monitoring experience required • At least 1 year of experience as an unmasked monitor required • Ophthalmology experience preferred, ideally in a retina indication • Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations and ICH guidelines • Ability to work independently and in a team matrix organization • Excellent written and verbal communication skills • Fluent in English and local language • Excellent organizational skills • Technology savvy with good software and computer skills • Ability to manage complex or early-phase studies • Ability and willingness to travel up to 60-80%, including overnight and international travel when applicable • Ability to work in a fast-paced environment with changing priorities • Self-awareness, flexibility, collaboration, proactivity, analytical approach, attention to detail, coachability, motivation, facilitation, and diplomacy • Ability to take ownership of assigned tasks

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Opportunity to make a difference in the lives of patients