Study Start Up Associate
Remote · Warsaw, Mazovia, Poland or Sofia, Sofia-Capital, Bulgaria
Job Summary
Study Start Up Associate responsible for facilitating site start-up and activation of clinical trials, assisting with regulatory document preparation and submissions (including ethics committee submissions), coordinating approvals with internal/external stakeholders, maintaining regulatory submission records, and supporting the development of study documents (protocols, informed consent forms, investigator brochures). Requires a life sciences Bachelor’s degree and English plus German/French/Italian language proficiency; experience in clinical research or regulatory affairs is preferred. Role involves collaboration with cross-functional teams and working in a fast-paced environment, with eligibility to work in the country where the role is based. Home or office-based in Poland (Warsaw) or in Bulgaria (Sofia) or Georgia (Tbilisi).
Required Qualifications
- Bachelor's degree in life sciences or related field
- Professional fluency in English and at least one of German, French, or Italian
- Experience in clinical research or regulatory affairs (preferred)
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal skills
- Ability to work independently and manage multiple tasks in a fast-paced environment
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