Covance

Clinical Research Associate II

Job Location(s) KR-Seoul
Job Number
2020-47296
Job Category
Clinical Research Associates
Position Type
Full-Time
Telecommute
No

Job Overview

Job Overview:
코반스 (Parent company: LabCorp)는 지속적인 성장과 체계적인 시스템 및 업무환경의 Global Top tier CRO로서, 매년 비지니스 확장과 직원수 증가로 현재 전세계 6만명 이상의 직원들이 근무하고 있습니다.
 
코반스 코리아는 Global CRO 중에서도 유일하게 전체 Spectrum, 즉 전 임상부터 Commercial 까지 Full service를 제공할 수 있는 유일한 CRO입니다. 한국은 2005년에 Legal entity 를 설립한 이후 1상부터 4상까지 다양한 indication 의 임상시험을 진행하고 있고, 정확하고 전문적인 성과로 더 크게 성장하고 있으며 직원들에게는 더 많은 커리어 기회를 제공하고 있습니다.
 
Responsibilities include, but are not limited to:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial 
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
- Gains an in-depth understanding of the study protocol and related procedures
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready
- Participates & provides inputs on site selection and validation activities
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
      - Data generated at site are complete, accurate and unbiased
      - Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required
 
Education/QualificationsEducational Requirements:
Preferred:
- B.A./B.S. with strong emphasis in Life science and/or biology
 
CORE Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyse data/metrics and act appropriately
 
Experience- 2+ years of CRA experience in CRO or Pharma company

Education/Qualifications

Education/QualificationsEducational Requirements:
Preferred:
- B.A./B.S. with strong emphasis in Life science and/or biology
 
CORE Competency Expectations:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
- Hands on knowledge of Good Documentation Practices
- Proven Skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyse data/metrics and act appropriately

Experience

Experience- 2+ years of CRA experience in CRO or Pharma company

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