Дата размещения:

23 июля 2008

Зарплата:

$1300

Электронная почта:

okodatska@spristudy.com.ua

Контактное лицо:

Kodatska Olga

Телефон рабочий:

+380 44 492 8055

Location: Kyiv

Responsibilities:
1. Periodically review clinical research sites, as directed by a project manager, and produce written reports in a timely manner
2. Assure the protection of the rights, safety and well being of human study subjects
3. To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP)
4. Identify, help in the study site selection process, initiate, and eventually close out clinical study sites
5. To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately
6. To make certain that the scientific integrity of the data collected is protected and verified
7. Assure that adverse events are correctly documented and reported
8. Review all case report forms and compare them to source documents
9. Other clinical trial-related activities for the sponsor such as site/investigator selection, study initiation activities, study termination activities, CRF processing/management activities (including in-house sponsor review and query resolution)
10. Management and training of junior research associates

Qualification:
• University Degree in medical/scientific field, pharmacy, biological science or related fields
• Fluent Russian, Ukrainian, and English
• Excellent communication and interpersonal skills (written and oral). Must be able to interact with study sites in a manner that reflects favorably on SPRI
• Detail-oriented
• Must have a proficient knowledge of medical terminology
• Must be willing and able to travel in Ukraine and abroad
• Thorough knowledge of Ukrainian clinical trial legislation and ICH/FDA Good Clinical Practices and documented training
• More than one year experience as a clinical trial monitor for pharmaceutical industry-sponsored projects

Desired Qualifications:
• Medical Doctor’s diploma
• Experience in at least 3 separate trials and with multi-center studies
• Fluency in another language (German, French, or Japanese)
• Experience managing a team of clinical professionals

Probation term:
3 months probation term at 100% salary
When is first salary review?
3 months (for probation period), then each 1 year