Senior Clinical Research Associate

TFS HealthScience - Contract Research Organization

Senior Clinical Research Associate overseeing clinical trials, ensuring compliance and data integrity for TFS HealthScience. Collaborating with teams to monitor and support study protocols effectively.

Posted 7/6/2026contractRemote • 🇵🇹 PortugalSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in monitoring clinical trials in compliance with GCP and ICH guidelines, ensuring participant safety and data integrity. Proficient in managing investigational products and maintaining regulatory documentation.

Highest-signal resume keywords

Clinical Trial MonitoringGood Clinical Practice (GCP)ICH GuidelinesMonitoring Visit ReportingBachelor’s Degree in Life Science or Nursing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

On-Site MonitoringData Integrity VerificationCRF ReviewInformed Consent ProceduresInvestigational Product ManagementRegulatory ComplianceTracking Systems UpdateProtocol Requirements UnderstandingMedical TerminologyTherapeutic Area Knowledge

Soft Skills

AdaptabilityAttention to DetailCommunicationProblem-SolvingTime Management

Tools & Technologies

ETMFPaper TMF

Industry Keywords

Clinical Research Associate (CRA)Regulatory RegulationsStudy Participant ProtectionSite File Maintenance

Tech Stack

Tools & technologies

Google 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

Requirements

What you’ll need

Bachelor’s Degree, preferably in life science or nursing; or equivalent
>3 years of experience as CRA including relevant on-site monitoring experience
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

Benefits

Comp & perks

Competitive compensation package
Comprehensive benefits
Opportunity for personal and professional growth