* 1년 계약직으로 근무후 정규직 전환 예정입니다.
Job Summary
- Responsible for monitoring of the designated clinical projects within the responsible territory
- Supporting administrative aspects of clinical projects
- Assuring the data quality of designated clinical projects
- Participating to the promotion of professional image as a clinical and scientific company
Main Responsibilities
- Ensure essential documents required to start the study at any particular site and the site administration paper work is accurate, complete and up-to-date
- Verify that agreements have been finalized and executed properly. This includes correct agreement has been received and proper signatures have been obtained
- Facilitate and track agreement renewals and IRB renewals
- Clinical study document filing as needed
- Maintain site visit log
- Coordinate mass mailings with study document tracking numbers
- Work with local Field Technical Engineers (FTEs) to ensure that all required case report forms and attachments of the responsible territory are collected and sent to the data management team within the required schedule of the patient visit
- Provide appropriate monitoring of designated clinical projects
- Perform initiation visits
- Ensure that original CRF entries mirror the source data (source data verification)
- Ensure that patients’ rights and well-being are observed
- Identify and obtain missing data and data corrections
- Ensure that all items listed in the Data Clarification Form (DCF), if any, are addressed with the required documents attached and sent to the data management team within schedule
- Assure clean data for data entry
- Perform site monitoring visits
- Write accurate, detailed and complete monitoring records within a timely manner and write follow-up letters to the site after a monitoring visit within a timely manner
- Ensure the clinical projects are occurring for completeness and accuracy of data as well as compliance with the study protocols, ID Clinical Standard Operating Procedures, laws and regulations
- Provide regular status reports to management
- Perform close-out visits
Qualification
- Bachelor’s degree and above in Science backgrounds.
- 2-4 years of relevant working experiences
담당자: 김대식
연락처: 02-6925-5391
이메일: ds@hrfind.co.kr