6 дней назад
Senior Clinical Research Associate
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Clinical Trials): Conducting site evaluation, training, monitoring, and closure activities for investigational drug or device trials in Guangzhou with an accent on protocol compliance, data integrity, patient safety, and site engagement. Focus on risk assessment, recruitment and retention planning, regulatory inspection readiness, and mentoring junior clinical research associates.
Location: Guangzhou, China
Company
develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Act as the primary sponsor contact for investigative sites and build effective relationships with investigators and site staff.
- Conduct site evaluation, training, routine on-site and off-site monitoring, and site closure activities.
- Ensure protocol compliance, data integrity, patient safety, timely safety-event reporting, and inspection readiness.
- Develop site engagement, recruitment, retention, and risk-mitigation strategies.
- Identify and evaluate investigators and potential sites for clinical studies.
- Mentor junior CRAs and contribute to global and local task forces.
Requirements
- Degree or tertiary qualification in a health-related discipline such as medicine, science, pharmacy, or nursing.
- At least 3 years of clinically related experience, including preferably 2 years of independent monitoring of investigational drug or device trials.
- Knowledge of therapeutic areas, clinical-trial execution, risk-based monitoring, and patient recruitment principles.
- Knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and standard operating procedures.
- Advanced communication, collaboration, planning, organizational, interpersonal, and presentation skills.
- Ability to independently assess clinical-site issues, apply critical thinking, and deliver timely, high-quality outcomes.
Culture & Benefits
- Work in a fast-paced clinical research environment focused on innovation and improving patient outcomes.
- Collaborate with internal R&D stakeholders, investigators, site staff, and monitoring teams.
- Operate according to ’s integrity standards, leadership values, quality requirements, and code of business conduct.
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