Senior Clinical Research Associate

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

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 requirements. • Perform all required monitoring activities to ensure subject safety, data integrity, and quality. • Verify the protection of study participants through informed consent procedures and protocol compliance in accordance with regulatory requirements. • Review CRFs (electronic or paper) and subject source documentation for validity, completeness, and accuracy and verify proper management and accountability of Investigational Product. • Prepare timely monitoring visit reports, document findings and corrective actions, update required tracking systems, and escalate issues as appropriate. • Ensure Investigator Site Files (ISF), eTMF documentation, CTMS records, and other study documentation are maintained in accordance with GCP, ICH guidelines, and regulatory requirements. • Support project-related activities including review of monitoring reports, site assessment visits, audit and inspection readiness, mentoring of CRAs, and other activities as required.

🎯 Requirements

• Bachelor's Degree, preferably in Life Sciences, Nursing, or equivalent. • More than 3 years of experience as a Clinical Research Associate, including significant on-site monitoring experience. • Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. • Experience managing clinical sites through initiation, monitoring, and close-out phases of clinical trials. • Excellent written and verbal communication skills, strong organizational abilities, and fluency in English.

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment