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.
We are currently looking for talented Senior Clinical Research Associates for our sponsor-dedicated position in Korea. (풀재택 논의 가능)
We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP and you will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
You will become a part of our team who is always ready to help. We offer a home-based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues.
Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us today.
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
- 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
- 2+ years of CRA experience in CRO or Pharma company