6 дней назад
Clinical Research Associate II
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II (Clinical Trials): Monitoring and coordinating investigative sites through study start-up, execution, and close-out with an accent on GCP compliance, regulatory requirements, data quality, and subject safety. Focus on conducting qualification and monitoring visits, resolving site issues, training site personnel, and maintaining inspection readiness across clinical studies.
Location: Belgrade, Serbia
Company
develops medicines and solutions for serious health conditions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Monitor clinical investigative sites through study start-up, execution, and close-out.
- Conduct site qualification, initiation, interim monitoring, and study closeout visits.
- Identify and resolve site issues, implement corrective actions, and maintain inspection readiness.
- Ensure protocol compliance, data quality, timely safety reporting, and protection of study subjects.
- Train site personnel on study protocols and regulatory requirements.
- Manage investigator agreements, payments, site identification, and related documentation.
Requirements
- Higher education in a health-related discipline such as medicine, science, or nursing is preferred.
- At least 1 year of clinically related experience, including at least 6 months of clinical research monitoring for investigational drug or device trials.
- Experience with risk-based monitoring and onsite and offsite monitoring.
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Strong planning, organization, collaboration, communication, presentation, and interpersonal skills.
- Ability to apply critical thinking and sound judgment when resolving clinical site issues in a fast-paced environment.
Culture & Benefits
- Work in a dynamic clinical operations environment with competing projects and deadlines.
- Collaborate with internal and external stakeholders and clinical site personnel.
- Operate according to ’s code of business conduct and leadership values.
- Equal opportunity employment with a focus on integrity, innovation, and community service.
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