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ThermoFisher Scientific Feasibility Site Specialist (FSS) in Seoul, South Korea

Job Description

Represents CRG in the global medical research community. Main point of contact for potential investigative sites through the feasibility process. Develops collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. Ensures sites receive necessary support and engagement, issues are resolved. Utilizes local knowledge, CRG systems, external sources including sponsor input to develop and review site lists that are suitable for the strategic needs of the feasibility and to support the site development strategy.

Essential Functions and Other Job Information:

  • Reports to a People Manager with the expectation of having a close collaboration with the local clinical operations management head and Feasibility Manager (FM).

  • Initiates feasibility intelligence collection based on study needs.

  • Assists in vetting local site lists, including research from internal and external sources to ensure the site list is reflective of the defined site profile.

  • Proactively identify risks to quality and compliance and develop and implement mitigation plans to address these risks.

  • Ensures current investigator and site staff contact details are appropriately maintained in CRG systems.

  • Collect and document in real time all communication attempts and follow up associated with site contact and feasibility essential documents in applicable CRG systems.

  • Responsible for primary investigator changes for the site in applicable CRG system.

  • Reviews DPA/ISD status of each site and collects and tracks documents in applicable CRG system as needed.

  • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. Communicates with the sites to clarify any responses, as needed. Updates applicable CRG system with appropriate questionnaire status.

  • Works to achieve targeted response goals for assigned projects. Communicates with the Strategic Feasibility team, appropriate local clinical team regarding site issues and feasibility risks.

  • Ensures an efficient, effective plan is in place for site contact and follow-up. Ensures compliance with the plan and escalates concerns to Feasibility Manager. Reviews with FM status of sites, at least weekly.

  • May act as the local expert regarding site capacity and expertise. Work with key local personnel to gather knowledge base and recommend additional sites. Where applicable, develops and maintains relationships with client local affiliates.

  • Champions the inclusion of Strategic Collaboration sites into the feasibility process

  • May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects. Further protocol and standard of care training would be provided.

  • Where applicable, conducts on-site feasibility visits.

  • Contributes to the development and roll out of global strategic feasibility processes and best practices.

  • Utilizes local knowledge to input into the identification and development of new sites within local market.

  • Expands therapeutic knowledge and expertise to assist in review of local country site lists. Demonstrated knowledge of site intelligence at local level in support of site recommendation.

  • Collect data from sites around their capabilities such as but not limited to electronic medical records, remote source document verification and facilitate the required checks from a technology level with the required departments such as CRG IT.

  • Assist Line Manager in developing agendas for team meetings.

  • Assist Line Manager in recording team meetings.

Qualifications

  • At a minimum, Associates degree or equivalent and relevant formal academic / vocational qualification.

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel and internal CRG teams

  • Excellent interpersonal skills

  • Strong attention to detail and quality of documentation

  • Good negotiation skills

  • Good computer skills and the ability to learn appropriate software

  • Fluency in local language as well as a good command of the English language and grammar skills

  • Basic medical/therapeutic area and medical terminology knowledge

  • Ability to work in a team environment or independently, under direction, as required

  • Basic organizational and planning skills

  • Basic knowledge of local health systems

  • Ability to attain and maintain a working knowledge of GCP and applicable SOPs

기타사항

  • 지원 과정에서 아래 사항에는 해당이 될 경우에만 Yes로 체크 해주시기 바랍니다. - (1) 써모피셔 사이언티픽 과거 또는 현재 재직여부 (2) 합병 관계사 재직여부 (3) 장애여부(disabled) (4) 보훈대상여부(veteran) (5) VISA Sponsorship 지원 필요 여부 (6) U.S. 연방정부 기관 근무 여부 (7) 고용 및 이직에 제한사항 여부

  • 고유식별정보(주민등록번호, 여권번호 등) 민감정보(종교, 정치 등)는 기재하지 마세요.

  • 보훈, 장애 대상자는 관련 서류 제출 시 관계법에 따라 우대합니다.

  • 영문이름은 여권상의 이름과 동일하게 기재하십시오.

  • 입사지원서 내용에 허위 사실이 판명될 경우, 입사가 취소될 수 있습니다.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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