Opening for Sr.CRA | China

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Sr.CRA | China

Responsibilities:

Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
Recruit investigators
Negotiate study budgets with investigators
Obtain, review, and process regulatory and administrative documents from investigator sites
Review and develop protocols
Review and develop CRFs
Coordinate and present at Investigators’ Meetings
Participate in proposal meetings with potential clients
Prepare and review Serious Adverse Event (SAE) reports
Prepare project management reports for clients, project personnel, and PharmaNet management
Resolve issues, questions, and requests for additional study supplies
Review and approve monitoring trip reports
Review and verify completed CRFs.
Review clinical data in-house.
Resolve queries of CRF data with study site personnel.
Review Tables and Listings generated from study data.
Author Clinical Study Reports.
Train and mentor CRAs on monitoring, internal procedures, and query resolution.
When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.
 

Requirements:

Bachelor’s Degree or nursing credential
Three and a half years’ experience in clinical research, data management, or regulatory affairs
Twenty four months’ field monitoring or equivalent experience
Ability and willingness to travel 50% of the time
Excellent organizational skills
Ability to manage time and work independently
Excellent written and oral communication skills
 

Country:

China [CN]