Clinical Research Associate



Желаемая должность Clinical Research Associate
Желаемая зарплата 15000 грн
Регион Киев
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Опыт работы

Medical Psychologist

Therapy-now, home based

Январь 2014 – настоящее время

Working with self growth, anger management, communication, depression, anxiety/fears/panic, abuse recovery (sexual, physical and emotional), trauma and age-related crisis.

Senior Clinical Research Associate

PAREXEL Ukraine LLC, Kyiv Ukraine

Октябрь 2006 – Сентябрь 2013

  - Mentoring and coaching of less experienced CRAs, visit reports review;   - Contract management of clinical studies;   - Regulatory management of clinical studies/ high knowledge of clinical research       regulations and practices;   - Developing of strategic plans for clinical studies, forecast timelines, budgets, resource needs     in alignment with the Clinical Operations Team objectives;
Clinical monitoring and management of 22 sites recruited 327 patients including but not limited to investigator/site selection/qualification, initiation, monitoring and termination, in accordance with PAREXEL´s SOPs, ICH GCP and Local Regulations. Detailed regular reporting to study team regarding enrollment status, visit reports, site contacts reports. Performing preventive and corrective actions, if necessary. Preparation to audit. Central File management and QC. Responsibility enclosing financial aspects of the study, working closely with Medical Department. Participating in business development activities including feasibility, consultation on bid development and estimation of critical success factors, scientific background, workload and timelines, personal participation in bid defense meetings. Development of study related documents – Monitoring Plan, Safety reporting Plan, instructions for investigators, presentation materials for investigator meetings etc. Supervising and support of Regulatory/CEC submission process

Ваш менеджер

  • (048) 784-14-75
  • (095) 286-42-32
  • (095) 286-42-33