Senior Clinical Research Associate (Sr. CRA) - Contractor - Remote

Overview

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

In Short

• Freelance role for up to 0.3-0.4 FTE.
• Remote position based anywhere in Bulgaria.
• Responsible for site management and monitoring activities associated with clinical studies.
• Perform site qualification, initiation, monitoring, and close-out visits.
• Ensure adherence to ICH GCP and local regulatory requirements.
• Complete and submit site visit reports timely.
• Act as primary point of contact for assigned sites.
• Assist in the development of study-related trackers and monitoring tools.
• Participate in study team meetings as required.
• Support Clinical Operations staff as needed.

Requirements

• Bachelor’s degree in science, medical health, or related discipline.
• English and Bulgarian language proficiency.
• A minimum of five years of clinical monitoring experience.
• Strong knowledge of ICH-GCP guidelines.
• Excellent oral and written communication skills.
• Good clinical and therapeutic knowledge.
• Proactive problem-solving skills.
• Strong attention to detail.
• Excellent computer skills.
• Experience with Microsoft Office products.

Benefits

• Work in a reputable international CRO.
• Opportunity to contribute to innovative clinical trials.
• Flexible working hours.
• Remote work environment.
• Collaborative team culture.
• Professional development opportunities.
• Engagement in various therapeutic areas.
• Supportive management.
• Access to company resources and training.
• Networking opportunities within the industry.