Freelance Clinical Research Associate

TFS HealthScience; Porto; Remote; EUR 18,000 - 30,000; Part time

Job summary

TFS HealthScience is seeking a Freelance Clinical Research Associate (0.2 FTE) for a one-year contract, home-based in Portugal. The role covers initiation, on-site and remote monitoring, and close-out activities across sites, with potential up to 0.3 FTE during peak periods.

Prior experience in Urology or Overactive Bladder is required. Join our Internal Medicine and Neuroscience team to ensure data integrity, patient safety, and regulatory compliance while collaborating across project teams in

Qualifications

• Bachelor's degree in life science or nursing required or equivalent.
• 1–3 years of relevant clinical experience or academic background in clinical trials.
• Experience in Urology or Overactive Bladder is required.
• Ability to work in a fast-paced environment with changing priorities.
• Good medical terminology understanding and scientific knowledge related to the assigned drugs and therapeutic areas.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Ability to work independently as well as in a matrix team.
• Excellent written and verbal communication skills.
• Willingness to travel up to 60–80% including overnight stays.

Responsibilities

• Monitor on-site and remote trials in accordance with GCP/ICH and regulatory regulations.
• Verify informed consent procedures and protocol compliance.
• Review CRFs and source documentation for accuracy.
• Verify Investigational Product accountability.
• Timely reporting of monitoring findings and CAPAs.
• Provide site with action items from monitoring visits.
• Ensure timely TMF/ISF updates and regulatory compliance.
• Participate in audits and inspections as needed.
• Order, ship, and reconcile clinical supplies if applicable.
• Update CTMS and project systems with site information.

Skills

Fluent English

Fluent Portuguese

Strong communication

Team collaboration

Travel readiness

Education

Bachelor's degree in life science or nursing

Job description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Freelance Clinical Research Associate (0.2 FTE) - home based in Portugal.

Whilst this opportunity is for 0.2 FTE, we may require you to work up to 0.3 FTE during some periods. This contract is for 1 year.

Prior experience in either Urology or Overactive Bladder is required.

About this role

As part of our Internal Medicine and Neuroscience team you will be working 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, will function operationally as a member of a Project Team and is responsible for the 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 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; escalation 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

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 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.
• 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 and 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.

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.