Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a key member of a Project Team

• Initiate, oversee, and conclude clinical study sites, either on-site or remotely

• Offer unmasked Clinical Research Associate (CRA) support for designated clinical studies

• Manage accountability for investigational products and supervise unblinded activities at sites

• Ensure compliance with protocols, subject safety, data integrity, and data quality

• Confirm adherence to informed consent procedures and protocol specifications

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

• Document actions, findings, and corrective/preventive measures from monitoring visits

• Communicate identified issues and necessary action items to sites

• Submit site documents to the electronic Trial Master File (eTMF) or paper Trial Master File (TMF)

• Ensure Investigator Site File maintenance complies with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and local regulations

• Update Clinical Trial Management System (CTMS) and other project systems with precise site information

• Engage in preparation and follow-up for audits and inspections

• Order, ship, and reconcile clinical investigative supplies as needed

• Assist Clinical Research or Project Managers with project tracking, monitoring plans, review of monitoring reports, and CRA resource management

• Conduct Assessment Site Visits upon request

• Mentor CRAs and create therapeutic-area training as required

• Take part in capabilities presentations

⛳️ Requirements

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

• Over 5 years of independent on-site monitoring experience

• Minimum of 1 year as an unmasked monitor

• Experience in ophthalmology is preferred, particularly related to retina indications

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

• Knowledge of basic medical terminology and scientific principles related to assigned drugs and therapeutic areas

• Familiarity with Good Clinical Practice regulations and ICH guidelines

• Ability to work autonomously and within a matrix team structure

• Exceptional written and verbal communication abilities

• Proficiency in English and the local language

• Strong organizational skills

• Technologically adept with solid software and computer skills

• Competence in managing complex or early-phase studies

• Willingness to travel 60–80%, including potential overnight and international travel

• Attributes such as self-awareness, determination, adaptability, collaboration, proactivity, analytical mindset, attention to detail, coachability, motivation, diplomacy, and ownership of tasks

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunities for personal and professional development

• A collaborative and innovative work environment

• Chance to make a significant impact on patients’ lives