8 дней назад
Clinical Research Associate (Clinical Trials)
100 500PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (Clinical Trials): Managing and monitoring investigator sites throughout clinical trials, from site initiation through database lock and close-out, with an accent on patient safety, GCP compliance, site quality, and protocol adherence. Focus on resolving site and protocol issues, supporting recruitment and database release, overseeing investigational products, and coordinating safety reporting and audit remediation.
Location: Remote in Poland
Minimum annual gross base salary: 100,500 PLN; annual bonus: 10%
Company
is a pharmaceutical company focused on developing medicines and improving patient health through clinical research and digital transformation.
What you will do
- Manage assigned investigator sites from study initiation through database lock and close-out.
- Conduct onsite and remote monitoring in accordance with monitoring plans, SOPs, applicable laws, Good Clinical Practices, and standards.
- Serve as the primary contact for investigator sites and coordinate information flow with study teams, vendors, and site personnel.
- Support site training, recruitment, enrollment, protocol compliance, and resolution of operational and clinical trial issues.
- Monitor adverse events and serious adverse events, resolve data queries, and maintain required trial documentation and reports.
- Oversee investigational product handling and support database release, audits, quality events, and corrective and preventive actions.
Requirements
- Must be based in Poland for the remote assignment.
- Knowledge of clinical trial operations, investigator site management, monitoring, and close-out activities.
- Understanding of the applicable laws, Good Clinical Practices, study protocols, monitoring plans, and standard operating procedures.
- Ability to manage investigator relationships, provide site training, resolve protocol-related issues, and support patient safety.
- Ability to conduct remote, electronic, and onsite monitoring and maintain accurate clinical trial documentation.
- Ability to collaborate with study teams, investigators, site staff, vendors, Drug Safety, and study clinicians.
Culture & Benefits
- Flexible workplace culture supporting work-life harmony.
- Corporate benefits including Medicover, Multisport, life insurance, and a private pension plan.
- Annual bonus of 10%.
- Patient-centric environment guided by courage, joy, equity, and excellence.
- Commitment to diversity, inclusion, accessibility, and reasonable adjustments during recruitment.
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