TFS HealthScience
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.
CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting
Clinical Research Associate - Junior/Senior
March 4
TFS HealthScience
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.
CRO • clinical trials • Scientific and Medical consulting • Contract Placement Solutions (staffing) • Regulatory Consulting
📋 Description
• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines • Perform all required monitoring activities to assess and ensure subjects safety, data integrity and quality • Verify the protection of study participants by informed consent procedures and protocol requirements • Review CRFs and subject source documentation for validity and accuracy • Verify proper management and accountability of Investigational Product • Report of actions taken during monitoring visits in Monitoring Visit Report • Provide sites with a listing of issues identified during monitoring visit and action items • Timely deliver site documents to eTMF or paper TMF • Verify that the Investigator's Site File is maintained in accordance with GCP and ICH guidelines • Update CTMS and all other required project systems with accurate site level information • Participate in audit and/or inspection preparation and follow-up activities as needed
🎯 Requirements
• Bachelor’s Degree in life science or nursing; or equivalent • >5 years of experience as CRA including relevant on-site monitoring experience • > 1 year prior CRA experience for junior candidates • Ability to work in a fast-paced environment with changing priorities • Understanding of basic medical terminology and science associated with assigned drugs • Understanding of Good Clinical Practice regulations, ICH guidelines • Ability to work independently and in a team matrix organization • Excellent written and verbal communication skills in English and German • Excellent organizational skills • Technology savvy with good software and computer skills • Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytic approach, attention to detail • Ability to take ownership of tasks • Ability to manage complex or early phases studies • Ability and willingness to travel up to 60-80%, overnight and abroad if applicable
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