CRA II \ Senior CRA

Дата размещения вакансии: 17.09.2020
Работодатель: ANCOR Consumer Goods
Уровень зарплаты:
з/п не указана
Город:
Москва
Требуемый опыт работы:
От 1 года до 3 лет

An international company opens a competition for a CRAII\ Sr. CRA.

Responsibility:

  • Develop strong site relationships and ensures continuity of site relationships through all phases of the trial;
  • Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents;
  • Gain an in-depth understanding of the study protocol and related procedures;
  • Perform remote and on-site monitoring and oversight activities;
  • Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit, non-visit contact reports appropriately in a timely manner;
  • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out;
  • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Support and/or lead audit/inspection activities as needed.

Requirements:

  • B.A./B.S. required with strong emphasis in science and/or biology;
  • Minimum 2 years of direct site monitoring experience in a bio/pharma/CRO;
  • Fluent in Russian and English (verbal and written) and excellent;
  • Communication skills;
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines;
  • Effective time management, organizational and interpersonal skills, conflic management, problem solving skills;
  • Ability to travel up to 75% of working time.

Conditions:

  • Highly competitive remuneration;
  • Comprehensive benefits package;
  • Family medical insurance;
  • Car allowance;
  • Additional vacation days;
  • Lunch allowance.