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Clinical Research Associate – Freelance
TFS HealthScience - Contract Research OrganizationClinical Research Associate monitoring clinical trials for TFS HealthScience. Responsible for ensuring data integrity and safety of study participants in a fully remote role.
Tech Stack
Tools & technologiesGoogle Cloud PlatformTFS
About the role
Key responsibilities & impact- 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
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
- 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
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial monitoringdata integrityinformed consent proceduresCRF reviewInvestigational Product managementMonitoring Visit ReporteTMFCTMSmedical terminologycardiovascular studies
Soft Skills
ability to work in fast-paced environmentadaptabilitycommunicationproblem-solvingattention to detailorganizational skillsteam collaborationtime managementcritical thinkinginterpersonal skills
Certifications
Bachelor’s Degree in life scienceBachelor’s Degree in nursingGood Clinical Practice (GCP) certification