Covance

In-house CRA

Job Location(s) KR-Seoul
Job Number
2020-47270
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.
 
The In-House CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the In House CRA shall reflect their experience, and level of contribution which they can make to the project.
 
The work will involve Operations activities which will be conducted for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The In House CRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOP’s and regulatory standards and guidelines applicable.
 
Essential Job Duties:
- To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
- To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
- Assist with the coordination of study visits and shipment of drug and laboratory samples.
- To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
- To liaise with the CTA to assist the Project Team in the production of Status Reports.
- To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region
- General On-Site Monitoring Responsibilities: Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
Education/Qualifications:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- In lieu of the above requirement, ·candidates with 2-3 or more years of relevant clinical ·Research experience in pharmaceutical or CRO industries may be considered
Experience (Minimum Required):
- Basic understanding of biology and biological processes
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibit general computer literacy
- Works efficiently and effectively in a matrix environment 
- At   least one year of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing). One year of clinical research is preferred. 
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- In lieu of the above requirement, ·candidates with 2-3 or more years of relevant clinical ·Research experience in pharmaceutical or CRO industries may be considered
                              

Education/Qualifications

 
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
- In lieu of the above requirement, ·candidates with 2-3 or more years of relevant clinical ·Research experience in pharmaceutical or CRO industries may be considered

Experience

 
Minimum Required:
- Basic understanding of biology and biological processes
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibit general computer literacy
- Works efficiently and effectively in a matrix environment 
- At   least one year of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing). One year of clinical research is preferred. 
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

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