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Freelance Clinical Research Associate
TFS HealthScience - Contract Research Organization. Function operationally as a member of a Project Team .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring clinical trials, ensuring compliance with SOPs, GCP, and ICH guidelines while maintaining subject safety and data integrity. Proficient in managing clinical study sites and effectively communicating site issues within a fast-paced, team-oriented environment.
Highest-signal resume keywords
Clinical Trial MonitoringGood Clinical Practice (GCP)ICH GuidelinesUrology ExperienceFluent in English and Portuguese
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study Site ManagementData Integrity AssessmentInformed Consent VerificationMonitoring Visit Report PreparationElectronic CRF ReviewInvestigational Product AccountabilityCTMS UpdatingAudit ParticipationMedical Terminology UnderstandingClinical Development Activities
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationExcellent Organizational SkillsAbility to Work IndependentlyAbility to Work in a Team
Tools & Technologies
ETMFTMFCTMSTracking SystemsClinical Investigative Supplies Management
Industry Keywords
Clinical TrialsLife ScienceNursingOveractive BladderFast-Paced Environment
About the role
Key responsibilities & impact- Function operationally as a member of a Project Team
- Initiate, monitor, and close out clinical study sites
- Monitor clinical trials on-site and remotely according to SOPs, GCP, ICH guidelines, and applicable regulations
- Perform monitoring activities to assess subject safety, data integrity, and quality
- Verify informed consent procedures and protocol compliance
- Review electronic or paper CRFs and subject source documentation
- Verify management and accountability of Investigational Product
- Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, and update tracking systems
- Communicate site issues and required action items
- Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance
- Participate in audits and inspections, including preparation and follow-up
- Order, ship, and reconcile clinical investigative supplies when applicable
- Update CTMS and other project systems with accurate site-level information
Requirements
What you’ll need- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- 1–3 years of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
- Experience in Urology or Overactive Bladder is required
- Ability to work in a fast-paced environment with changing priorities
- Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas
- Understanding of Good Clinical Practice regulations and ICH guidelines
- Ability to work independently and in a team matrix organization
- Strong written and verbal communication skills
- Fluent in English and Portuguese
- Excellent organizational skills
- Technology savvy with good software and computer skills
- Ability and willingness to travel up to 60–80%, overnight and abroad if applicable
Benefits
Comp & perks- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
- Collaborative and innovative work environment
- Team focused on making a difference in patients’ lives