CPA2
上海, 中国
职位描述
Responsibilities:
• Trial and site administration:
o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non‐clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents
o Assist with eTMF reconciliation
o Updating manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Execute eTMF Quality Control Plan
o Obtain translations of documents
• Regulatory & Site Start‐Up responsibilities:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Develop country and site budgets (including Split site budget)
o Tracking, and reporting of negotiations
o Maintenance of tracking tools
o Working knowledge of Contract development, negotiation, approval and maintenance (e.g. CTRAs)
o Update and maintain contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants)
o Ensure compliance with financial procedures
o Monitor and track adherence and disclosures
o Budget closeout.
o Obtain and process FCPA documentation in a timely manner
• Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable
Requirement:
*B.A./B.S. (Life Science preferred) or equivalent healthcare experience;
*Minimum 1‐2 years in Clinical Research or relevant healthcare experience
Note ‐ Specific experience requirements may vary depending on the Country
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
