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- 포지션: SSU CRA (Clinical Research Associate II)
- 계열사: 한국얀센 (Janssen Korea)
- 근무지: 서울시 용산구
- 근무형태: 정규직(regular)
A SSU CRA serves as the primary contact point between the Sponsor and the Investigational Site. A SSU CRA is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through before site initiation. Responsibilities may include assisting with site selection, pre-trial assessment, etc. Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. SSU CRA may contribute to process improvement, training and mentoring of other Site Managers.
1. Acts as primary local company contact for assigned sites for specific trials.
2. May participate in site feasibility and/or pre-trial site assessment visits
3. Responsible for executing activities within start-up, preparation and site management (by study specific systems and other reports/dashboards) according to SOPs, Work Instructions (WIs) and policies.
4. Ensures site staff are trained and the corresponding training records are complete and accurate at study start up phase. Responsible in close collaboration with LTM and central study team for the activities during site start up phase in order to speed up the process and activate the site in shortest possible timeframe.
5. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
6. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
7. Fully documents trial related activities, in particular pre-trial assessment visit. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
8. Collaborates with LTM for documenting and communicating site/study preparation and issues to trial central team.
9. Attends regularly scheduled team meetings and trainings.
10. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
11. Tracks costs at site level and ensure payments are made, if applicable.
12. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
13. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
14. Acts as a point of contact in site start-up practices.
15. May be assigned as a coach and mentor to a less experienced site manager.
16. May contribute to process improvement and training.
17. Leads and/or participates in special initiatives as assigned.
18. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- A minimum of 3 year of clinical trial monitoring experience is required. however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English.
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1905778893W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
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Janssen Korea, Ltd. (7220)
Clinical Trial Administration