가천대학교

[회사 소개]

한국애브비

당사의 전세계 3만명에 이르는 직원들은 과학자, 연구자, 커뮤니케이터, 제조전문가, 규제 관련 전문가들입니다. 우리는 생명을 위협하는 질환부터 만성 질환에 이르기까지 당면한 건강 문제들을 해결하기 위해 새로운 접근법을 모색하고 있습니다. 우리는 당사의 핵심 R&D 전문역량을 활용할 수 있는 완치가 힘든 특정 질환들에 집중하고 있습니다. 우리는 질환치료와 그 이상을 지원하는 솔루션을 개발해 환자의 삶과 우리 사회 그리고 과학 분야에 긍정적인 영향을 주기 위해 끊임없이 노력하고 있습니다.

Title: Clinical Project Assistant

Department: Clinical Site Management
Reporting To: Clinical Operations Manager

Targeted Onboarding Month: Feb 2022 (육아휴직 대체) 

– 12월 중에는 인터뷰 과정만 진행될 가능성이 있습니다.

간략 업무 요약

물품 수입 통관 업무

- 임상 시험에 필요한 병원의 심험약/환자 체혈 kit – device 쪽 신고 허가업무

- 물건 수입 시 Broker communication

Payment Support

Other Overall Admin

Purpose:
Describe the primary goals, objectives or functions or outputs of this position.
Anticipates and identifies issues that could affect the quality of data, systems or processes and develops alternative solutions, or ensures corrective action is implemented as appropriate. If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and Quantum. The key impact of this role is to ensure, through their contribution to the local Clinical team, that Site Management & Monitoring fulfills its commitment to the global organization.

Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
•The Clinical Project Assistant (CPA) provides administrative and clinical management support to Site M&M personnel and assist them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted within the country.

•If applicable, creates a local trial file for the filing of Country specific original documentation. Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents. Supports CRAs with translation of Clinical Study documents and local Clinical Team with preparations for PSVs, SIVs, and COVs, as necessary. 

•Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensures the Investigator Site Files are crated, contain the correct and complete documentation, and are shipped as appropriate to the Investigational Sites. Internal/ External Contacts and Interactions: Uses multiple technologies to maintain open and frequent communication with Site Management & Monitoring personnel. Maintains a positive working relationship with internal/external customers. 

•May be assigned as the local updater of databases (such as IMPACT) with Country related data, if applicable. If applicable, assists in forwarding safety information to the appropriate group. In-house support for CRAs during site visits (administrative tasks, point of contact etc.) 

•Acts as in-house support for CRA’s with the handling and destruction arrangements of Investigational Product as, and if, required. This may include the entering of relevant information into Interactive Web-based Reporting Systems. Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs). 

•Participates in pre-audit activities to meet both PV and GCP Audit requirements. Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility. Ensures financial information for assigns studies/sites is entered into company systems in a timely manner and is managed in compliance with company policies (ex US). May participate in global Task Forces and Initiatives. 

•Supports Clinical Team with the processing of Expense Reports and Travel arrangements. Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.). If appropriate, assists with the filing of training records and other relevant personnel documentation for staff. •If applicable, supports relevant Line Managers with the onboarding process of new staff. Supports Affiliate Clinical Team with the updates to local SOP’s and Work Instructions, when applicable. Actively participates in relevant Meetings, manages the collection and distribution of mail and courier
requests and may act as a local liaison for CRO (Observational) Studies.

•May interface with and build professional collaborative relationships with: Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Safety Representatives, Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas. 

•Site Management and Monitoring personnel in other Countries and Document Management. External service providers 

•Study personnel (investigators, study coordinators, pharmacists, etc.) 

•Peers within the organization vendors.

[자격요건]

•Preferred background in life-science or health-care related qualification or experience is desired. 

•Preferred with a proven track record of success in a Site M&M Department and a basic knowledge related to ICH/GCP Guidelines and applicable local regulations. 

•Basic awareness of the conduct of clinical trials and its associated activities and responsibilities. 

•Previous administrative experience is desired. 

•Proven negotiating skills, tact and diplomacy. 

•Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. 

•Ability to manage multiple priorities/projects, communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management. Proactive and positive team player. •Written and verbal fluency in English and local language (if not English). Familiarity with all standard IT office tools. •Proven ability to communicate effectively within a multi-cultural/global team environment. 

•Exhibits high level of flexibility when facing changes in the work environment.

[근무조건]
근무시간: 월요일~금요일(주 5일) 09:00 ~ 18:00
근무위치: 서울시 강남구 삼성역 인근
고용형태: 맨파워 소속 파견계약직
계약기간: 1년 (육아휴직 대체직)
입사 예정일: 2022년 2월

 
복리후생
- 4대보험, 연차, 퇴직금 등 근로기준법 준수
- Summer Vacation 지원비
- 명절 상품권 지원
- 생일/명절 선물
- 창립기념일 상품권 지원
- 경조 휴가/각종 경조금
- 우수 근무자 포상

[지원방법]

- 국영문 이력서 및 자기소개서 (MS Word 양식)

- 이메일 지원: ellen.seol@manpower.co.kr

- 이메일 제목: [애브비_CPA_성명]