TFS HealthScience - Contract Research Organization
501 - 1000 employees
Founded 2007
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
Clinical Research Associate – Freelance
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TFS HealthScience - Contract Research Organization
501 - 1000 employees
Founded 2007
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
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
• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. • Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality. • Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations. • Review CRFs (electronic or paper) and subject source documentation for validity and accuracy. • Verify proper management and accountability of Investigational Product. • Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate. • Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner. • Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements. • Participate in audit and/or inspection, its preparation and follow-up activities, as needed. • Order, ship, and reconcile clinical investigative supplies for study sites, if applicable. • Update CTMS and all other required by projects systems with accurate site level information.
🎯 Requirements
• Bachelor’s Degree, preferably in life science or nursing; or equivalent • Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities • Able to work in a fast-paced environment with changing priorities. • Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas. • Possess the understanding of Good Clinical Practice regulations, ICH guidelines. • Experience with cardiovascular studies with Medical Devices is a big plus.
🏖️ Benefits
• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth
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