[Hiring] Freelance Clinical Research Associate @TFS HealthScience

Role Description

Join Our Team as a Freelance Clinical Research Associate (0.2 FTE) - home based in Portugal. This contract is for 1 year, with potential to work up to 0.3 FTE during some periods. Prior experience in either Urology or Overactive Bladder is required.

As part of our Internal Medicine and Neuroscience team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Freelance Clinical Research Associate is part of Clinical Development Services (CDS) within TFS HealthScience, functioning operationally as a member of a Project Team responsible for:

• Initiation, on-site and/or remote monitoring, and close out of study sites during study conduct, according to company policies, SOPs, and regulatory requirements.

Key Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures, GCP, 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.
• Provide site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely deliver site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP, 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 project systems with accurate site-level information.

Qualifications

• 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 any of the following areas is required: Urology or Overactive Bladder.
• 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 understanding of Good Clinical Practice regulations and ICH guidelines.
• Ability to work independently as well as 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.
• Soft skills: Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail.
• 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 in a rewarding environment.
• Join a team that values collaboration, innovation, and making a difference in the lives of patients.