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[ICON plc - Core Team] CRA, SSUA 채용공고
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
If you’re as driven as we are, join ICON plc. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Currently we are hiring CRAs and Study Start-Up Associates to be based in Seoul, Korea.
Position : Clinical Research Associate I, II and Senior (0명)
- Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II– III ensuring that applicable regulations and principles of ICG-GCP are adhered to.
- Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
-Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested.
-Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.
- Managing sponsor generated queries efficiently and responsible for study cost effectiveness.
- Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects.
- 1+ year of experience in site monitoring
- Preferred monitoring experience in phase I~III trials as CRA
- Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
- Good command of English as well as the local language
- Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
- Ability to produce accurate work to tight deadlines within a pressurized environment
- Computer literate with Microsoft Office
- Must be available to travel international and domestic at least 60% fly
- Must hold a bachelor’s degree in pharmacy, nursing, science, or equivalent
Position : Study Start Up Associate I and II (0명)
- Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
- Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams.
-Responsible for the preparation and coordination of submissions to ethics and other bodies.
- Develop, finalize and review Master and Country Specific Subject Information Sheets/Informed Consent Forms.
- Review and translate Drug labels.
- Perform in dependent quality review of submission packages.
-Responsible for the translation and co-ordination of translations for documents required for submission.
- Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system.
-Responsible for the timely follow-up for queries made by EC.
-Responsible for the collection of critical documents required for IP Release.
-Responsible for the collection and maintenance of the current Ethics Committee(EC)submission information, and similar information for other related.
- Comply with all department requirements regarding information provision and status updating and reporting
- A minimum of 1 year of experience in Study Start-up area
- Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)
- Good organizational skills and the ability to manage multiple tasks
- An excellent level and proven experience high standards of attention to detail
-Proficient in English and language required for country assignments
- Strong project management skills
- Highly developed problem solving skills
- Strong people management and effective communication skills
- Customer service focused
-Bachelor’s degree or local equivalent and/or with appropriate experience from the Medical/science background and/or discipline
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.
◉ 근무지: 서울, 2호선 역삼역 3번출구 도보 1분거리
- 근무형태: 정규직
- 급여: 면접시 협의 (Attractive Compensation & Benefits Package)
- 근무요일/시간: 월-금, 8시간/일 (Flexible working hours: 10:00~16:00 core time)
- 연차 : 첫해 15일/년, 매년 1일씩 추가 최대 25일
- Sick Leave : 10일/년
- Life Events Leave : 3-7일/년
- 식사/식대 제공 여부 : 점심식대 및 야근 시 저녁식대 청구가능
◉ 복리후생 :
- Wellness benefit allowance
- Group life & medical insurances
- Performance Incentive
- 경조사비 지원
◉ 전형절차: 서류전형 -> HR면접 -> 부서장 면접/임원면접
◉ 지원방법: 영문이력서를 Jennifer.email@example.com으로 송부
◉ 제출서류: 경력중심 영문이력서
-담당자 및 연락처: Jennifer Kim(김지연), Talent Acquisition Specialist
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