Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a member of a Project Team throughout the execution of clinical studies.

• Initiate, remotely and on-site, monitor, and close out study sites.

• Provide unbiased CRA support, which includes oversight of investigational product accountability and unblinded site activities.

• Oversee clinical trials in compliance with SOPs, GCP, ICH guidelines, and relevant regulations.

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

• Confirm adherence to informed consent procedures and protocol requirements.

• Assess the validity and accuracy of CRFs and source documentation.

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

• Communicate site challenges and necessary action items.

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

• Ensure proper maintenance of the Investigator Site File.

• Keep the CTMS and other project systems updated with correct site information.

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

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

• Support Clinical Research or Project Managers with tracking projects, monitoring plans, report evaluations, and CRA resource management.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training in therapeutic areas as needed.

• Participate in capabilities presentations.

⛳️ Requirements

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

• At least 5 years of independent on-site monitoring experience is essential.

• A minimum of 1 year of experience as an unmasked monitor is required.

• Experience in ophthalmology is preferred, particularly in retina indications.

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

• Knowledge of Good Clinical Practice regulations and ICH guidelines is necessary.

• Ability to work both independently and as part of a team in a matrix organization.

• Outstanding written and verbal communication skills are essential.

• Proficiency in English and the local language is required.

• Strong organizational skills are a must.

• Technology savvy with proficient software and computer skills.

• Capability to manage complex or early-phase studies effectively.

• Willingness to travel up to 60-80%, including overnight and international travel when required.

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

• Attributes such as self-awareness, flexibility, collaboration, proactivity, analytical mindset, attention to detail, coachability, motivation, facilitation, and diplomacy are important.

• Ability to take ownership of assigned responsibilities.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.

• Collaborative and innovative work environment.

• Chance to make a difference in the lives of patients.