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*Observational study CRA (not interventional)
-觀察性研究CRA可以接受全國任何城市候選人
-可以接受home base
-具備6個月及以上CRA工作經(jīng)驗
-英文流利,Fortrea內(nèi)部向global LM匯報
Essential Job Duties:
1) Responsible for all aspects of study site monitoring
including routine monitoring and closeout of clinical sites, maintenance of
study files, conduct of pre-study and initiation visits; liaise with vendors;
and other duties, as assigned
2) Responsible for all aspects of site management as
prescribed in the project plans
3) General On-Site Monitoring Responsibilities:
4) Ensure the study staff who will conduct the protocol have
received the proper materials and instructions to safely enter patients into
the study
5) Ensure the protection of study patients by verifying that
informed consent procedures and protocol requirements are adhered to according
to the applicable regulatory requirements
6) Ensure the integrity of the data submitted on Case Report
Forms (CRFs) or other data collection tools by careful source document review
7) Monitor data for missing or implausible data
8) 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
9) Ensure audit readiness at the site level
10) Travel, including air travel, may be required and is an
essential function of the job.
11) Prepare accurate and timely trip reports
12) Interact with internal work groups to evaluate needs,
resources and timelines
13) Act as contact for clinical trial supplies and other
suppliers (vendors) as assigned
14) Responsible for all aspects of registry management as
prescribed in the project plans
15) Undertake feasibility work when requested
16) participate in and follow-up on Quality Control Visits
(QC) when requested
Experience:
Minimum Required:
? Six (6) months experience in a related role (e.g. site
management, in-house CRA, study coordinator, research nurse, etc.)
? Basic understanding of Regulatory Guidelines
? Ability to work within a project team
? Good planning, organization and problem solving skills
? Good computer skills with good working knowledge of a
range of computer packages
? Works efficiently and effectively in a matrix environment
? Valid Driver's License
Preferred:
? One (1) or more year's additional experience in a related
field (i.e. medical, clinical, pharmaceutical, laboratory, research, data
analysis, data management or technical writing) is preferred
? 6 months on site monitoring experience
Education/Qualifications/Certifications and Licenses
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.
? Basic knowledge of Regulatory Guidelines
? Basic understanding of the clinical trial process
? Fluent in local office language and in English, both
written and verbal
Preferred:
? Working knowledge of Covance SOPs regarding site
monitoring
Competencies: FOR GLOBAL REWARDS USE ONLY: Template Revised
– October 2018 Page 5 of 5
Required: Core Level
1) Focus on Customer - Level 2 (Supports)
2) Innovate and Change - Level 1 (Understands and Considers)
3) Pursue Scientific and Process Excellence - Level 1
(Understands and Considers)
4) Work with Others - Level 2 (Supports)
5) Achieve Results - Level 2 (Supports)
6) Ability to maintain confidentiality of data and
information during interactions with staff at all levels and across studies and
sponsors
7) Demonstrated ability to conduct clinical operations
activities most effectively and efficiently.
8) Attention to detail
9) Methodical approach to work
10) Understanding of medical and clinical research
terminology and clinical research processes
11) An understanding of the basics of physiology,
pharmacology and medical devices (when applicable)
12) Understanding of the principles of ICH GCP, ISO 14155
(if applicable) and regulatory requirements
13) Good computer literacy with working knowledge of PCs,
Windows and Microsoft Office applications
14) Good oral and written internal and external
communication. Strong interpersonal team and organizational skills, personal
presentation. The ability to communicate effectively in English.
15) Experience using a clinical trial management system
(CTMS)
16) For medical device positions, experience in providing
customer service to device end users
Working Conditions:
General Office Environment or Home-Based Office