4 дня назад
Senior Clinical Research Associate
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Clinical Trials/GCP): Managing and monitoring investigator sites across the clinical trial lifecycle with an accent on patient safety, regulatory compliance, site quality, and study execution. Focus on resolving site-level issues, supporting enrollment and database release, conducting on-site and remote monitoring, and preparing for audits and inspections.
Location: Istanbul, Turkey; remote and field-based with significant travel
Company
is a patient-centric pharmaceutical company focused on developing breakthroughs that improve patients' lives.
What you will do
- Manage and monitor assigned investigator sites throughout study start-up, execution, and closeout.
- Conduct site initiation, routine monitoring, closeout, remote, electronic, and co-monitoring visits.
- Ensure compliance with protocols, GCP, applicable regulations, and standards.
- Support site activation, patient recruitment, enrollment, database release, and investigational product oversight.
- Maintain study documentation, monitoring reports, protocol deviation records, and Trial Master File documentation.
- Identify site issues, implement corrective and preventive actions, resolve data queries, and support audit readiness.
Requirements
- Bachelor's degree in Life Sciences or an equivalent healthcare-related discipline such as Nursing, Pharmacy, or Medicine.
- At least 3 years of clinical research site monitoring experience.
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and local regulations.
- Global clinical trial experience and strong knowledge of clinical research and development processes.
- Fluency in English and Turkish or other local language requirements for the country of employment.
- Valid driver's license and passport; significant international and weekend travel may be required.
Nice to have
- Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases.
- Experience with protocol development, feasibility assessment, risk management, regulatory inspections, or audits.
- Experience mentoring Clinical Research Associates or serving as a subject matter expert for CRA processes.
Culture & Benefits
- Flexible workplace culture supporting work-life harmony.
- Opportunities for leadership development through rotations.
- International career opportunities and a diverse, inclusive work environment.
- Participation in regional, local, and global process improvement initiatives.
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