We are hiring Start-up Associate in Covance Hong Kong! The role will bases in our client's office and responsible for submission and clinical trial administration. welcome to join us if you have related clinical trial experience.
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
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
-B.A./B.S. (Life Science preferred) or equivalent healthcare experience
-Minimum 1-2 years in Clinical Research or relevant healthcare experience
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.