Freelance Clinical Research Associate

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

📋 Description

• Operate effectively as a part of a Project Team.

• Initiate, oversee, and conclude clinical study sites during the study process.

• Conduct oversight 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 standards.

• Confirm informed consent processes and compliance with protocols.

• Assess electronic or paper Case Report Forms (CRFs) and source documentation for subjects.

• Ensure proper management and accountability of the investigational product.

• Create Monitoring Visit Reports, document findings along with corrective and preventive actions, and update tracking systems accordingly.

• Raise concerns and deficiencies as necessary.

• Communicate identified issues and required action items to study sites.

• Submit site documents to the electronic Trial Master File (eTMF) or paper Trial Master File (TMF) and ensure the maintenance of the Investigator Site File.

• Engage in audits or inspections, including necessary preparation and follow-up actions.

• Order, ship, and reconcile clinical investigative supplies as required.

• Keep the Clinical Trial Management System (CTMS) and other project systems updated with precise site-level information.

⛳️ Requirements

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

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

• Familiarity with Advanced Therapy Medicinal Products (ATMPs), Obsessive Compulsive Disorder, Cardiovascular studies, or Observational Studies.

• Capability to thrive in a dynamic environment with shifting priorities.

• Knowledge of basic medical terminology and science related to assigned drugs and therapeutic areas.

• Comprehension of Good Clinical Practice regulations and ICH guidelines.

• Competence to work autonomously as well as within a team matrix organization.

• Strong written and verbal communication abilities.

• Proficient in English and Polish.

• Exceptional organizational skills.

• Proficient in technology, with solid software and computer skills.

• Willingness and ability to travel up to 60–80%, including overnight and international travel as necessary.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• The chance to positively impact patients’ lives.