Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as part of a Project Team.

• Initiate, oversee on-site and/or remote activities, and finalize study sites during the study process.

• Offer unmasked support as a Clinical Research Associate for designated clinical studies.

• Manage accountability for investigational products and supervise unblinded site operations.

• Monitor clinical trials in accordance with TFS and/or sponsor SOPs, GCP, ICH guidelines, and relevant regulations.

• Conduct monitoring activities to evaluate subject safety, data integrity, and data quality.

• Verify informed consent processes and adherence to protocol.

• Review electronic or paper Case Report Forms (CRFs) and subject source documents for accuracy and validity.

• Document actions, findings, and corrective and preventive measures from monitoring visits; update tracking systems and escalate issues as necessary.

• Provide identified issues and necessary action items to study sites.

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

• Ensure Investigator Site File maintenance in compliance with GCP, ICH, and local regulatory requirements.

• Update Clinical Trial Management System (CTMS) and other project systems with precise site-level data.

• Engage in audit and inspection preparations, participation, and follow-ups.

• Order, ship, and reconcile clinical investigational supplies as needed.

• Assist the Clinical Research Manager or Project Manager with tracking projects, reviewing monitoring plans and reports, and managing CRA resources.

• Conduct Assessment Site Visits upon request.

• Mentor Clinical Research Associates when designated.

• Develop and implement training related to therapeutic areas for CRAs and project team members when assigned.

• Participate in capability presentations when required.

• Collaborate with study teams, investigative sites, and sponsors to ensure timely delivery of objectives while preserving study blinding and data quality.

⛳️ Requirements

• Bachelor’s Degree, preferably in a life science or nursing, or equivalent qualifications.

• Over 5 years of independent on-site monitoring experience.

• Minimum of 1 year of experience as an unmasked monitor.

• At least 1 year of experience in Ophthalmology preferred, ideally within retina indications.

• Familiarity with basic medical terminology and scientific principles related to assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Ability to work autonomously and within a team matrix organization.

• Exceptional written and verbal communication skills.

• Proficient in English and the local language.

• Strong organizational skills.

• Tech-savvy with proficient software and computer skills.

• Capability to manage complex or early-phase studies.

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

• Self-awareness, determination, adaptability, a collaborative spirit, proactivity, analytical thinking, attention to detail, receptiveness to coaching, motivation to embrace new challenges, effective discussion facilitation, and diplomacy in challenging situations.

• Ability to take ownership of assigned responsibilities.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.