2 дня назад
Clinical Research Associate II/III (Bulgaria)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II/III (Clinical Research): Conducting independent clinical trial monitoring and managing study sites in Bulgaria with an accent on ICH GCP compliance, data review, and investigator communication. Focus on identifying risks, preparing CAPA plans, supporting regulatory submissions, and negotiating site budgets and contracts.
Location: Sofia, Bulgaria (Hybrid)
Company
is a mid-sized global Contract Research Organisation delivering agile, patient-focused clinical development across diverse therapeutic areas.
What you will do
- Conduct pre-study, initiation, interim monitoring, and closeout site visits independently.
- Manage assigned sites through regular communication with site personnel, supporting compliance, enrolment, and understanding of study requirements.
- Perform CRF review, generate and resolve queries, and work with applicable data review guidelines or data management systems.
- Identify and escalate risks, recommend retraining, and prepare and follow CAPA plans through timely resolution.
- Prepare documents for ethics committee submissions and notifications, including translations where applicable.
- Negotiate study budgets, support site contract execution, and administer site payments.
Requirements
- University degree, preferably in medical or life sciences, nursing, or another relevant healthcare discipline.
- At least 1–2 years of independent clinical trial monitoring experience.
- Strong knowledge of ICH GCP Guidelines and regulatory requirements, with an interest in clinical research.
- Fluent Bulgarian and English, written and verbal, are required.
- Computer proficiency, strong scientific and technical reading skills, and excellent communication, interpersonal, and negotiation abilities.
- Ability to work independently and effectively in a matrix environment; a current, valid driver’s license is required.
Nice to have
- Experience in nephrology, urology, or infectious diseases.
Culture & Benefits
- FSP working model with flexible work hours and work-from-home options.
- Performance and referral bonuses.
- Additional health insurance and well-being initiatives.
- Employee engagement programs and training and development opportunities.
- Collaboration with an international clinical research team operating across multiple countries.
Hiring process
- Submit a CV for consideration.
- Only shortlisted candidates who meet the requirements will be contacted for the next selection stage.
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