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Senior Clinical Research Associate – Freelance
TFS HealthScience - Contract Research OrganizationSenior Clinical Research Associate monitoring clinical trials to ensure subjects safety and data integrity. Join TFS HealthScience in contributing to clinical development for pharmaceutical companies.
ATS Keywords
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Hard Skills
clinical trials monitoringdata integrityinformed consent proceduresCRF reviewInvestigational Product managementMonitoring Visit Reportcorrective actionspreventive actionstracking systemsclose-out visits
Soft Skills
communicationattention to detailproblem-solvingorganizational skillsteam collaboration
Certifications & Qualifications
Bachelor’s DegreeGood Clinical Practice certification
Industry Keywords
life sciencenursingclinical developmentICH guidelinesregulatory compliance
Tech Stack
Tools & technologiesTFS
About the role
Key responsibilities & impact- Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard.
- 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.
- Monitoring Close-out visits in Ukraine.
Requirements
What you’ll need- 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.
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
- Fluent in English and Ukrainian.
Benefits
Comp & perks- We provide opportunities for personal and professional growth in a rewarding environment.
- You will join a team that values collaboration, quality, and making a difference in the lives of patients.
- Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture.