Clinical Research Associate II/III - Bulgaria

At Optimapharm, you'll have the opportunity to work on diverse and meaningful projects that help bring innovative therapies to patients worldwide. As part of our international team, you'll collaborate with experts across multiple disciplines, gain exposure to a broad range of therapeutic areas, and contribute to research that makes a real difference.

With colleagues in 26 countries and operations in more than 40 countries, we combine global reach with the agility, collaboration, and supportive culture of a mid-sized organisation. Here, your expertise is valued, your growth is encouraged, and your work has a visible impact.

We’re looking for a sponsor dedicated CRA (CRA II - III, depending on experience) to join our team in Bulgaria. Whether you’re building your expertise as a CRA I or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide. This role sits within a defined CRA career path: CRA I → CRA II → CRA III → Senior CRA. 

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 1-2 years of independent clinical trial monitoring experience (nephrology/urology, infectious diseases experience is a plus)
• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
• Fluent in local language and English, both written and verbal
• Computer proficiency is mandatory
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro-active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

• →Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
• →Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
• →Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
• →Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• →Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
• →Preparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisor
• →Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
• →Administration of site payments in accordance with relevant project instructions

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.