임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

시험자와 의뢰자의 임상연구코디네이터의 근무환경과 활용방안에 대한 인식

Perception on Working Conditions and Utilization of Clinical Research Coordinators among Investigators and Sponsors

  • 정인숙 (부산대학교 간호대학) ;
  • 최상민 (부산대학교병원 임상시험센터) ;
  • 윤지향 (부산대학교 간호대학) ;
  • 윤은화 (부산대학교병원 임상시험센터)
  • Jeong, Ihn-Sook (College of Nursing, Pusan National University) ;
  • Choe, Sang-Min (Clinical Trial Center, Pusan National University Hospital) ;
  • Yoon, Ji-Hyang (College of Nursing, Pusan National University) ;
  • Yun, Eun-Hwa (Clinical Trial Center, Pusan National University Hospital)
  • 투고 : 2012.01.09
  • 심사 : 2012.05.10
  • 발행 : 2012.06.30
⟨ 이전 논문 다음 논문 ⟩

초록

Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and ${\chi}^2$ test or t test. Results: Among investigators and sponsors, 56.1% and 95.0% perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5% of investigators and 68.8% of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4% of investigators perceived lack of experienced CRCs and 84.8% of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6% of investigators and 58.0% of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.

키워드

과제정보

연구 과제 주관 기관 : 보건복지부

참고문헌

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