8 часов назад
Clinical Research Associate II (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II (Oncology): Monitoring and coordinating oncology clinical studies at investigative sites in compliance with protocols, SOPs, ICH-GCP, and applicable regulations with an accent on site management, regulatory submissions, and study risk mitigation. Focus on conducting pre-study and initiation visits, identifying investigators, managing site progress, and supporting complex Phase I, CAR-T, and FIH studies.
Location: Remote, Spain; candidates must reside in Madrid or Barcelona. Domestic travel, including overnight stays, may account for approximately 50–60% of the role.
Company
Precision for Medicine is a specialized contract research organization supporting precision medicine, oncology, rare disease, and targeted clinical trials.
What you will do
- Monitor and own the progress of clinical studies at investigative sites.
- Ensure studies are conducted, recorded, and reported according to protocols, SOPs, ICH-GCP, regulations, and applicable standards.
- Coordinate study start-up and monitoring activities, including investigator identification and regulatory submissions.
- Conduct pre-study and initiation visits and support ongoing site management.
- Identify study risks, propose mitigation strategies, and manage challenges and conflicts.
Requirements
- At least two years of CRA experience in a CRO, pharmaceutical, or biotechnology company, or equivalent relevant experience and demonstrated competencies.
- Site management or equivalent clinical research experience.
- Oncology monitoring experience.
- Four-year college degree or equivalent experience.
- Residence in Madrid or Barcelona and availability for domestic travel of approximately 50–60%.
- Fluency in English and Spanish, the local language required for the country of employment.
Nice to have
- Graduate or postgraduate degree in a scientific or healthcare discipline.
- Phase I clinical trial experience.
- Experience managing CAR-T or FIH studies.
Culture & Benefits
- Remote work arrangement within Spain.
- Reasonable travel expectations and a focus on work-life balance.
- Lower-than-average protocol assignments to support deep protocol expertise.
- Direct line management support and opportunities to influence company decisions.
- A collaborative environment where employee input and ideas are valued.
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