諾佛葛生技顧問股份有限公司
Study Nurse 研究護理師 (台北地區) (12 months)
9/18 Cập nhật
Array
Toàn thời gian
Cấp nhân viên trung cấp
Công việc không hoàn toàn online
Lương & địa điểm làm việc
Thỏa thuận
(Thường từ 40.000NTD trở lên)
新北市淡水區
Điều kiện
Yêu cầu ngôn ngữ
Tiếng Anh
聽/精通、說/精通、讀/精通、寫/精通
Tiếng Trung
聽/精通、說/精通、讀/精通、寫/精通
Kinh nghiệm
1年以上
Mô tả công việc
Please do submit English resume to our company website.
https://fa-euzi-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/2683/?utm_medium=jobshare
Brief Position Description:
The Study Nurse is responsible for planning, directing, and managing clinical trials at site. The Study Nurse also implements remote site management activities according to the Site Management Plan, ensuring that clinical trials are conducted and documented, as per protocol, ICH GCP guidelines and applicable regulatory requirements and SOPs.
Reporting to:
As indicated on current organisation chart.
Responsibilities:
Conduct and complete remote site management activities and/or on-site visits according to the Site Management Plan. Specific duties include:
Serve as a primary point of contact for site communication.
Implement study start-up activities including but not limited to gathering feasibility information, negotiation of contract and budgets, planning for subject recruitment, communication with IRB/IEC.
Collaborate with the principal investigator to prepare IRB/IEC and any other regulatory submission documents as required per protocol, ICH-GCP and local regulations.
Ensure amendments to an approved protocol, informed consent form, and other relevant documents are submitted to IRB/IEC for approval as required and assure that changes are not implemented prior to approval.
Arrange with monitor the scheduled date, time and location of site initiation visit. Prior to the site initiation visit, review the Investigator's Brochure and any up-to-date information on the investigational product for assessment of risk/benefit ratio of study participation in order to set Site Management Service Plan.
Perform study-related tasks delegated by the principal investigator within the contracted scope. Study Nurse is responsible for performing tasks appropriate for its role, unless otherwise noted on a protocol specific delegation of authority log.
Support the investigator to identify suitable subjects for screening according to the eligibility criteria. If necessary, assist the principal investigator to use directed and IRB/IEC approved advertising (newspaper, TV, Internet advertisements, posters, etc.) materials.
Provide written and verbal site updates on study progress to the line manger according to the
study requirements/timelines. Ensure adequacy of information and data contained in site visit reports and other site management documents.
Manage the site expenses of clinical trial including but not limited to subject reimbursement, material cost, travelling expense, cost for technical information, utilities and fees.
Số lượng tuyển dụng
1~1人
Trình độ học vấn
大學(學院)以上
Giờ làm việc
日班
Chế độ nghỉ
依公司規定
Loại công việc
Registered Nurse and Nurse
Research Nurse
Other Medical Staff
台北市中山區
其他醫療保健服務業
Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.
Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.
Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary carers, and regular training, learning, and international knowledge-sharing opportunities.
