社名
社名非公開
職種
アプリケーションスペシャリスト、クリニカルスペシャリスト
業務内容
...
Primary FunctionOur company is seeking a dedicated and ambitious Clinical Study Specialist (CRA) to join our team. This mid-level position in Clinical Research is ideal for those aspiring to start or advance their career in the Medical Device industry, specifically focusing on clinical trials. This role is perfect for individuals who aim to become Clinical Project Managers (Clinical Study Managers) in the future.Under the supervision of Clinical Project Managers, the Clinical Study Specialist will assist in planning, designing, and executing high-quality clinical studies to ensure the safety and effectiveness of the company’s products. Proficiency in English is crucial, as it will significantly enhance career development and future opportunities. The role requires compliance with international and local regulations, handling confidential patient and company data, and interfacing with various internal and external stakeholders. Depending upon Clinical requirements may be directly involved in the monitoring of trials.■Major Responsibilities・Participates in the site qualification and initiation process, including scheduling monitoring activities with site personnel.・Assists Clinical management with the development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.・Drafts informed consents under direct supervision.・Gathers documents and information for clinical investigator and laboratory selection.・Manages device accountability, inventory, and distribution.・Based upon Clinical requirements, may monitor on-going compliance to study protocols and site adherence to regulatory guidelines.・Prepares and participates in presentation of protocols and other study conduct requirements at investigational sites.・Oversees subject screening and enrollment at assigned clinical sites.・Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and sponsor file.・Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.・Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s. Assists in query writing and resolution process, as required. Identifies and gathers missing or incomplete data from the investigational sites.・Reviews Case Report Forms (CRF’s) for clinical content.・Conducts site visits, as necessary. Acting as a company liaison, works with clinical sites to resolve any site related issues quickly and effectively.・Provides on-call help for sites, as well as on-going site training.・Assists Clinical staff with the development and implementation of corrective actions for addressing noncompliance issues at individual sites and across study.・Assists Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. ・Assists with study site audits.・Assists with on-going literature searches.・Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions.
求められる経験
Minimum Education & Experience:
・Bachelor’s-level degree required.
Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
・2-3 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required.
・One year of clinical monitoring experience required.
・Project management experience preferred.
Working Conditions:
・General office environment, and includes approximately 30-70% travel to research laboratory or hospital settings, meetings and/or other company facilities, depending on project’s phase.
・Potential exposure to blood borne pathogens and other potentially infectious materials.
Competency Expectations:
・Good verbal and written communication skills.
・Excellent interpersonal and organizational skills.
・Detail oriented and good problem solving ability.
・Ability to work on teams and with multiple projects.
・Working knowledge of medical terminology required.
・Excellent computer skills (experience with spreadsheets and word processing programs).
・Familiar with laws, regulations, standards and guidance governing the conduct of clinical studies.
・Proficiency in English, with the ability to work effectively in a global environment and seize international career opportunities.
#LI-DNI
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収750 ～ 1,150万円
賞与
-
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
アプリケーションスペシャリスト、クリニカルスペシャリスト
業務内容
...
Primary FunctionOur company is seeking a dedicated and ambitious Clinical Study Specialist (CRA) to join our team. This mid-level position in Clinical Research is ideal for those aspiring to start or advance their career in the Medical Device industry, specifically focusing on clinical trials. This role is perfect for individuals who aim to become Clinical Project Managers (Clinical Study Managers) in the future.Under the supervision of Clinical Project Managers, the Clinical Study Specialist will assist in planning, designing, and executing high-quality clinical studies to ensure the safety and effectiveness of the company’s products. Proficiency in English is crucial, as it will significantly enhance career development and future opportunities. The role requires compliance with international and local regulations, handling confidential patient and company data, and interfacing with various internal and external stakeholders. Depending upon Clinical requirements may be directly involved in the monitoring of trials.■Major Responsibilities・Participates in the site qualification and initiation process, including scheduling monitoring activities with site personnel.・Assists Clinical management with the development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.・Drafts informed consents under direct supervision.・Gathers documents and information for clinical investigator and laboratory selection.・Manages device accountability, inventory, and distribution.・Based upon Clinical requirements, may monitor on-going compliance to study protocols and site adherence to regulatory guidelines.・Prepares and participates in presentation of protocols and other study conduct requirements at investigational sites.・Oversees subject screening and enrollment at assigned clinical sites.・Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and sponsor file.・Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.・Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s. Assists in query writing and resolution process, as required. Identifies and gathers missing or incomplete data from the investigational sites.・Reviews Case Report Forms (CRF’s) for clinical content.・Conducts site visits, as necessary. Acting as a company liaison, works with clinical sites to resolve any site related issues quickly and effectively.・Provides on-call help for sites, as well as on-going site training.・Assists Clinical staff with the development and implementation of corrective actions for addressing noncompliance issues at individual sites and across study.・Assists Clinical staff in identifying sites to be audited by either Corporate Compliance or Clinical staff. ・Assists with study site audits.・Assists with on-going literature searches.・Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions.
求められる経験
Minimum Education & Experience:
・Bachelor’s-level degree required.
Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred.
・2-3 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required.
・One year of clinical monitoring experience required.
・Project management experience preferred.
Working Conditions:
・General office environment, and includes approximately 30-70% travel to research laboratory or hospital settings, meetings and/or other company facilities, depending on project’s phase.
・Potential exposure to blood borne pathogens and other potentially infectious materials.
Competency Expectations:
・Good verbal and written communication skills.
・Excellent interpersonal and organizational skills.
・Detail oriented and good problem solving ability.
・Ability to work on teams and with multiple projects.
・Working knowledge of medical terminology required.
・Excellent computer skills (experience with spreadsheets and word processing programs).
・Familiar with laws, regulations, standards and guidance governing the conduct of clinical studies.
・Proficiency in English, with the ability to work effectively in a global environment and seize international career opportunities.
#LI-DNI
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収750 ～ 1,150万円
賞与
-
雇用期間
期間の定めなし
show more
