Код вакансии: 11.906
Вакансия: Clinical Compliance Officer
Компания: Leading International pharmaceutical company
Требования:
* Medical or life sciences background, at least 1,5 year of clinical research experience.
* QA/ Audit training, preparation and participation in different types of audits, at least 2 audits passed.
* Scientific acumen is essential.
* Good communication skills.
* Fluent oral and written English
Обязанности:
* Co-monitoring visits to sites monitored by contract or internal monitors with corrective recommendations and follow up.
* Regular quality control of study files.
* Ensure compliance with regulatory requirements according to the approval conditions, company SOPs and applicable laws and regulations.
* To agree training plan for CRO monitors.
* To provide support for the clinical trials quality related issues, provide consultations on ICH GCP and FDA regulations and guidelines.
* To assess new contract and internal staff GCP, SOPs knowledge (tests, interviews).
* To support sites during central audit/ inspections preparations.
* To support CRO monitors in case of quality and GCP issues.
* To participate in the work of LOC Quality Team.
Заработная плата: от 80000 рублей
