Clinical Research Associate II/III - Bulgaria
Sofia, Sofia-City, Bulgaria · Full-time · Not Applicable · Posted
About the role
📌 Location: Bulgaria
🎯Who we are?
Optimapharm is a mid-sized, global Contract Research Organisation turning science into hope through agile, patient-focused clinical development.
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.
🎁 What do we offer?
Working in a successful company that’s growing and developing every day
Being part of a clinical research team that transforms science into hope for patients
FSP working model
Performance bonus
Referral bonus
Flexible work hours
Work from home
Additional health insurance
Employee engagement programs
Well-being initiatives
Training and development program
🔎 Who are we looking for?
💼 Qualifications And Experience
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
📑 Your responsibilities
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.