Clinical Research Excellence
Senior Clinical Research Associate
Location
Israel
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
TFS HealthScience - Contract Research Organization
• 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.
Job 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
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