Covance

CRA II

Job Location(s) CN-Shanghai
Job Number
2021-61850
Job Category
Clinical Research Associates
Position Type
Full-Time
Telecommute
No

Job Overview

Essential Job Duties:
1) The below statements are intended to describe the general nature of the job and are not
intended to be an exhaustive list of all responsibilities, skills and duties.
2) Responsible for all aspects of study site monitoring including routine monitoring and
close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
visits; liaise with vendors; and other duties, as assigned
3) Responsible for all aspects of site management as prescribed in the project plans
4) General On-Site Monitoring Responsibilities
5) Ensure the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
6) Ensure the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the applicable
regulatory requirements
7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other
data collection tools by careful source document review
8) Monitor data for missing or implausible data
9) Ensure the resources of the Sponsor and Covance are spent wisely by performing
the required monitoring tasks in an efficient manner, according to SOPs and
established guidelines, including managing travel expenses in an economical
fashion according to Covance travel policy
10) Ensure audit readiness at the site level
11) Travel, including air travel, may be required and is an essential function of the job.
12) Prepare accurate and timely trip reports
13) Responsible for all aspects of registry management as prescribed in the project plans
14) Undertake feasibility work when requested
15) Participate in and follow up on Quality Control Visits (QC) when requested
16) Recruitment of potential investigators, preparation of EC submissions, notifications to
regulatory authorities, translation of study-related documentation, organization of
meetings and other tasks as instructed by supervisor
17) Might be requested to work in a client facing environment
18) Track and follow up on Serious Adverse Event (SAE) reporting, process production of
reports, narratives and follow up of SAE
19) Independently perform CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems
as assigned by management
20) Assist with training, of new employees, e.g. co-monitoring
21) Coordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
22) Perform other duties as assigned by management

Education/Qualifications

Minimum Required:
• University or college degree, or certification in a related allied health profession from an
appropriately accredited institution (e.g., nursing licensure). An equivalent amount of
experience can be substituted as appropriate.
• Thorough knowledge of ICH Guidelines and understanding of local regulatory
requirements
• Thorough knowledge of monitoring procedures
• Basic understanding of the clinical trial process
• Valid Driver's License
Preferred:
• Thorough knowledge of Company SOPs regarding site monitoring

Experience

Minimum Required:
• A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an
equivalent combination of education and experience to successfully perform the key
responsibilities of the job can be substituted.
• Ability to monitor study sites independently according to protocol monitoring
guidelines, SOP, and local regulatory Guidelines
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process
production of reports, narratives and follow up of SAEs
• Good planning, organization and problem- solving abilities
• Ability to work with minimal supervision
• Good communication and interpersonal skills
• Good analytical and negotiation skills
• Computer competency
• Fluent in local office language and in English, both written and verbal
• Works efficiently and effectively in a matrix environment
Preferred:
• One (1) or more additional years of experience in a related field (i.e. medical,
clinical, pharmaceutical, laboratory, research, data analysis, data management or
technical writing) is preferred, however an equivalent combination of education
and experience to successfully perform the key responsibilities of the job.

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