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): Conducting and overseeing clinical site activities in Beijing with an accent on protocol compliance, patient safety, data integrity, and site engagement. Focus on risk-based monitoring, resolving site risk signals, supporting patient recruitment, and maintaining audit and regulatory inspection readiness.
Location: Beijing, China
Company
develops innovative medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Act as the primary point of contact for investigative sites and build effective partnerships with investigators and site staff.
- Train and motivate site personnel and principal investigators on trial goals, protocols, and patient treatment principles.
- Conduct site evaluations, training, routine monitoring, and site closure activities in line with protocols, monitoring plans, GCP, ICH Guidelines, and company SOPs.
- Support patient recruitment and retention, assess site performance, and develop site engagement strategies using CRM tools.
- Perform ongoing risk assessments, resolve site risk signals, and implement preventive and corrective action plans.
- Ensure data quality, timely safety reporting, audit and inspection readiness, and appropriate investigator payments.
Requirements
- Degree or tertiary qualification in a health-related discipline such as medicine, science, or nursing.
- At least one year of clinically related experience, including at least six months of clinical research monitoring for investigational drug or device trials.
- Experience with risk-based monitoring and onsite and offsite monitoring activities.
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and clinical trial policies.
- Strong planning, organization, communication, presentation, interpersonal, and cross-functional collaboration skills.
- Ability to apply critical thinking and sound judgment to clinical site issues in a dynamic environment.
Nice to have
- Knowledge of relevant therapeutic areas, indications, scientific concepts, and patient journeys.
- Experience mentoring or training less experienced Clinical Research Associates.
Culture & Benefits
- Work in an environment focused on innovation, integrity, and transforming patient lives.
- Opportunities to participate in global or local clinical research task forces and initiatives.
- Equal opportunity employment and commitment to an inclusive workplace.
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