Freelance Clinical Research Associate
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Job Description
Freelance Clinical Research Associate monitoring clinical trials for TFS HealthScience, a global contract research organization. Ensuring site compliance, participant safety, data integrity, and regulatory quality.
Responsibilities:
- 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:
- 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:
- 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
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