• Job Description

  Req#: TFSCGLOBALR01228516EXTERNALENGLOBAL

  Job Description

  At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

  Assistant CRA (ACRA, Inhouse CRA)

  • Location: Remote / Office / Hybrid
  • Type: Regular (정규직)
  • Team: Core Clinical

  Summarized Purpose:

  Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

  Key responsibilities:

  • Completes study and site management activities as defined in task matrix, and as applicable and advised for study assigned.
  • Completes and documents study-specific training.
  • Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
  • Supports site staff with the vendor related qualification process, where applicable.
  • Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
  • Provides support to follow-up on site staff training, as applicable.
  • Coordinates and supports logistics for IM attendance, as advised.
  • Supports maintenance of vendor trackers, as advised.
  • Coordinates study/site supply management during pre-activation and subsequent course of the study.
  • Supports Crucial Document collection, review and updating in systems, as applicable.
  • Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as advised.
  • Supports ongoing remote review of centralized monitoring tools, as advised.
  • Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as advised and follows-up on site invoices throughout the study period.
  • Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
  • Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as advised.
  • May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
  • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

  Requirements

  • Bachelor's 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).
  • Basic medical/therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations and CRG procedural documents
  • Effective oral and written communication skills
  • Excellent interpersonal and customer service skills
  • Good interpersonal and time management skills and strong attention to detail, with proven track record to handle multiple tasks efficiently and optimally
  • Proven flexibility and adaptability
  • Ability to work in a team or independently, as the need arises
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Proficient digital literacy with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
  • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
  • Excellent English language and grammar skills

  기타사항

  • 지원 과정에서 아래 사항에는 해당이 될 경우에만 Yes로 체크해주시기 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.

  • Our 4i Values:

  Integrity – Innovation – Intensity – Involvement

  • Our Mission:

  Our Mission is to enable our customers to make the world healthier, cleaner and safer.

  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  Apply today! http://jobs.thermofisher.com

  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.

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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