Study Start-Up CRA

工作内容

Job Description

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role]! #GCO.

Job Purpose:

Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager

• Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments. Accountable for timely start-up activities from country allocation until site greenlight at assigned sites. Conducts site selection visits, verifies site eligibility for a specific study
• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation. Ensures that milestones (KPIs) and time schedule for study start-up are met as planned. Facilitates the preparation and collection of site and country level documents
• Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines. Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities. Prepare and finalize site specific documents for submission. Negotiates investigator payments as needed
• Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed. Updates all systems until site Green Light on an ongoing basis. Supports preparation of audits and inspections as applicable
• Supports reduction of formal site-specific IRB/IEC deficiencies. Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to
  

ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health

Authority and SOP requirements

• Implements innovative and efficient processes which are in line with Novartis strategy. Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU. Manager for review and approval.
  

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education:

• A degree in scientific or health discipline, preferably with clinical operations experience (or, for United States: 4-year degree plus relevant, related healthcare experience) Languages:
• Fluent in both written and spoken English, local language as needed Experience/Professional requirement:
• Minimum 3 years’ experience in clinical operations in a
  

monitoring / site management role

• Advanced understanding of all aspects of clinical drug
  

development with particular emphasis on trial set-up,

execution, and monitoring

• Central/in-house monitoring or field monitoring experience is
  

desirable

Division

Global Drug Development

Business Unit

GCO GDD

Country

Taiwan

Work Location

Taichung City

Company/Legal Entity

Novartis (Taiwan) Co. Ltd

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No