Clinical Research Associate
- Company
- 외국계 CRO 회사
- Position
- Clinical Research Associate
- Status
- OPEN
다음과 같이 외국계 CRO 회사에서‘CRA’담당자를 찾습니다.
* Job Title: CRA (Clinical Research Associate)
* 직급: 사원급 (경력 2~3년)
* Location: 서울
[RESPONSIBILITIES]
- Identify potential sites and to assess their suitability for the proposed study in conjunction with the CRM.
- Prepare and/or review clinical trial documents such as Protocol, ICF and CRF etc.
- Prepare and/or conduct IND/IRB submission dossier and ensure that IRB and MFDS are updated regarding protocol amendments, SAE(if applicable) etc.
- If requested, organize investigator meetings/project meetings and present at the meetings.
- Assemble investigator site files and ensure that all required documents are in place prior to release of clinical supplies. Conduct initiation, interim monitoring visits, and close-out visits.
- Undertake monitoring visits within the correct timelines and ensure all monitoring activities such as source data verification and drug accountability are completed.
- Writes a monitoring report after each type of visit, in which the tasks performed during the visit and any problems encountered are reported, along with follow-up on any outstanding issues.
- Write confirmation letter and follow-up letter for the purpose of on-site quality optimization.
- Maintain and file documents in TMF in order to accurately reflect the progress of the study.
- Distribute and track clinical trial supplies, e.g. ICF, lab kits and ensure that sites have sufficient supplies to continue the study.
- Perform site management like as tracking patient recruitment on a regularly basis for individual sites.
- Prepare and/or submit the Project Status Files to the sponsor.
- Communicate with data management staffs regarding data flow and data query processing.
- Use all reasonable endeavors to work precisely according to schedules and timelines, established by the Sponsor and CRM for the conduct and completion of the study.
- Undertake other project related tasks, as assigned by CRM.
- Undertake non-project related tasks as appropriate as assigned by the CRM and/or CO Director.
- Participates in the education of persons conducting clinical trials, etc.
- Develop collaborative relationships with investigator sites and the sponsor personnel.
- Assist in a variety of projects as required; and perform such other duties as may be assigned.
[QUALIFICATIONS]
- BS or Associate degree in Life Science, Nursing, or a related field or an equivalent combination of experience and training that provides the required knowledge, skills, and abilities.
- Ability to understand MFDS regulation, Good Clinical Practice and ICH-guideline.
- Good clinical knowledge with understanding of medical terminology.
- Understanding of the basics of physiology, pharmacology, medications etc.
- Alternatively equivalent previous experience in a clinical development or nursing environment.
- Good computer literacy with working knowledge of Microsoft Office applications, etc.
- Good command of spoken and written English.
- Good oral and written communication and co-ordination skills.
- Ability to communicate with the CRM, other CRAs/staff and Sponsor as appropriate.
- Previous experience of clinical research, if no experience in clinical research, it requires completion of certified training course to meet the regulatory requirement.
- Ability to work in a timely manner under the supervision of the CRM.
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently.
Only qualified candidates will be contacted for interview.
All resumes not contacted will be kept in DB confidentially for future positions.
Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Email: ceo@exdigm.com
