Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a key member of a Project Team

• Initiate, oversee, and conclude study sites both on-site and remotely during the study execution

• Offer unmasked Clinical Research Associate support for designated clinical studies

• Manage investigational product accountability and supervise unblinded site activities

• Ensure protocol compliance, participant safety, data integrity, and data quality are maintained

• Confirm informed consent processes and adherence to protocol requirements

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

• Document actions taken during monitoring visits, findings, corrective and preventive measures, and update tracking systems accordingly

• Escalate any deficiencies or issues as necessary

• Communicate identified issues and required action items to the sites

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

• Ensure Investigator Site File is maintained in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and local regulatory standards

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

• Engage in audit and inspection preparation as well as follow-up activities

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

• Assist Clinical Research or Project Managers with project tracking, monitoring plans, report reviews, and management of CRA resources

• Conduct Assessment Site Visits upon request

• Mentor Clinical Research Associates and create therapeutic-area training when required

• Take part in capabilities presentations

⛳️ Requirements

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

• Over 5 years of independent on-site monitoring experience

• Minimum of 1 year of experience as an unmasked monitor

• Experience in ophthalmology preferred, particularly in retina indications

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

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

• Knowledge of Good Clinical Practice regulations and ICH guidelines

• Proficiency in working independently as well as within a team matrix organization

• Exceptional written and verbal communication skills

• Fluent in English and the local language

• Strong organizational skills

• Proficient with technology and competent in software and computer usage

• Capability to manage complex or early-phase studies

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

• Attributes such as self-awareness, determination, flexibility, collaborative mindset, proactive attitude, analytical thinking, attention to detail, coachability, and motivation to embrace new challenges, along with the ability to facilitate discussions and demonstrate diplomacy in challenging situations

• Capacity to take ownership of assigned responsibilities

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunities for personal and professional development

• Collaborative and innovative work environment

• Chance to positively impact patients’ lives