Freelance Clinical Research Associate

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Operate effectively as a member of a Project Team

• Initiate, oversee, and conclude clinical study sites

• Conduct monitoring of clinical trials both on-site and remotely, adhering to SOPs, GCP, ICH guidelines, and relevant regulations

• Execute monitoring tasks to evaluate subject safety, data integrity, and quality

• Confirm informed consent procedures and ensure protocol compliance

• Examine electronic or paper Case Report Forms (CRFs) and subject source documentation

• Ensure the management and accountability of Investigational Product

• Compile Monitoring Visit Reports, document findings and corrective/preventive actions, and update tracking systems

• Communicate site-related issues and necessary action items

• Submit site documents to eTMF or paper TMF and ensure the maintenance of the Investigator Site File

• Engage in audits and inspections, including preparation and follow-up activities

• Order, ship, and reconcile clinical investigative supplies when necessary

• Update CTMS and other project systems with precise site-level information

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing; or an equivalent qualification

• 1–3 years of relevant clinical experience or a pertinent academic background in clinical trial or clinical development activities

• Experience in Urology or Overactive Bladder is essential

• Capability to operate in a fast-paced environment with shifting priorities

• Familiarity with basic medical terminology and the science related to assigned drugs and therapeutic areas

• Knowledge of Good Clinical Practice regulations and ICH guidelines

• Ability to work independently as well as within a team matrix organization

• Strong written and verbal communication abilities

• Proficiency in both English and Portuguese

• Exceptional organizational skills

• Technologically adept with strong software and computer skills

• Willingness to travel up to 60–80%, including overnight and international travel if required

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunity for personal and professional development

• Collaborative and innovative work environment

• Team dedicated to making a positive impact on patients’ lives