Senior Clinical Research Associate (Medical)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Research Associate (Medical): Conducting clinical monitoring for assigned protocols and investigational sites with an accent on data cleaning and regulatory compliance. Focus on performing site initiation, interim, and close-out visits, ensuring adherence to GCP and local regulatory requirements.
Location: Must be based in Serbia (Belgrade); hybrid and remote options are supported.
Company
provides specialized consulting solutions to biotech, med device, and pharmaceutical organizations to de-risk and accelerate drug and device programs.
What you will do
- Conduct all types of monitoring and co-monitoring visits (initiation, interim, close-out) both in-person and remotely.
- Write detailed monitoring reports within SOP and local regulatory parameters.
- Perform study start-up activities, including site identification, feasibility, and Ethics Committee submissions.
- Review source documents and case report forms for accuracy, completeness, and integrity to resolve data issues.
- Manage investigational supplies, including dispensing, inventory, and reconciliation.
- Collaborate with clinical sites, investigators, and cross-functional teams to address study needs.
Requirements
- Serbian language proficiency is required.
- Over 5 years of experience as a Clinical Research Associate (CRA).
- Bachelor's degree or an equivalent combination of education and experience.
- Strong knowledge of ICH Guidelines, GCP, and local regulatory requirements.
- Practical experience with EDC, CTMS, IVRS, and eTMF systems.
- Ability to prioritize tasks and work with minimal supervision.
Culture & Benefits
- Commitment to diversity, equity, and inclusion, creating a safe space for authentic self-expression.
- Support for remote working with an encouraged hybrid model for those near office locations.
- Personal review of all applications by the recruitment team without reliance on AI screening tools.
- Entrepreneurial and collaborative work environment.
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