1 час назад
Clinical Research Associate II
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
Clinical Research Associate II (Clinical Trials): Conducting remote and onsite monitoring activities across clinical studies in Spain with an accent on data integrity, patient safety, regulatory compliance, and trial documentation. Focus on planning investigator-site visits, maintaining TMF/eTMF records, reviewing essential documents, and delivering timely monitoring reports across phases I–IV, with emphasis on phases II and III.
Location: Spain; fully remote, hybrid, or office-based arrangements are available. Country-wide monitoring is expected, with an average of 6 onsite days per month.
Company
supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.
What you will do
- Conduct remote, onsite, and other approved monitoring activities in line with country regulations, focusing on data integrity and patient safety.
- Plan daily monitoring activities, set priorities by site, and prepare and conduct qualification, initiation, interim, and close-out visits.
- Prepare timely monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
- Maintain TMF/eTMF records according to filing guidelines and organizational processes.
- Review site documents for accuracy, completeness, currency, and required updates.
- Submit travel and expense reports in accordance with company requirements.
Requirements
- Undergraduate degree or international equivalent in a clinical, scientific, or health-related field, a licensed healthcare professional qualification, or equivalent work experience.
- Previous clinical research experience.
- At least 2 years of experience in clinical trials and independent monitoring.
- Knowledge of essential clinical trial documents under ICH/GCP Section 8.
Nice to have
- Experience in neurology, oncology, rare diseases, or pediatrics.
- Experience working across phases I–IV; candidates with experience limited to phases II and III will also be considered.
Culture & Benefits
- Flexible choice of fully remote, hybrid, or office-based work.
- Opportunities to develop skills and grow professionally.
- Work designed to support flexibility and work-life balance.
- Employee ideas and input influence how work is performed.
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