Covance

Sr Clin Res Assoc I

Job Location(s) CN-Beijing
Job Number
2021-61845
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 closeout
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) Manage small projects under direction of a Project Manager/Director as assigned
a. Serve as lead monitor for a protocol or project, and may assist in establishing monitoring
plans and trip report review as assigned
14) Review progress of projects and initiate appropriate actions to achieve target objectives
15) Organize and make presentations at Investigator Meetings
16) Participate in the development of protocols and Case Report Forms as assigned
17) Participate in writing clinical trial reports as assigned
18) Interact with internal work groups to evaluate needs, resources and timelines
19) Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
20) Responsible for all aspects of registry management as prescribed in the project plans
21) Undertake feasibility work when requested
22) Conduct, report and follow-up on Quality Control (QC) visits when requested
23) 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 as assigned
24) Negotiate study budgets with potential investigators and assist the Covance legal
department with statements of agreements as assigned
25) Track and follow-up on Serious Adverse Event (SAE) reporting, process production of
reports, narratives and follow up of SAEs
26) Independently perform CRF review; query generation and resolution against
established data review guidelines on Covance or client data management systems as
assigned by management
27) Assist with training, mentoring and development of new employees, e.g. co-monitoring
28) Coordinate designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as assigned
29) 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)
• In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
• Thorough knowledge of regulatory requirements
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
• Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Preferred:
• Thorough knowledge of company SOPs regarding site monitoring

Experience

Minimum Required:
• Two (2) years of Clinical Monitoring experience
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Advanced site monitoring skills
• Advanced study site management skills
• Advanced registry administration skills
• Ability to work with minimal supervision
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Advanced verbal and written communication skills
• Ability to train and supervise junior staff
• Ability to resolve project-related problems and prioritizes workload for self and team
• Ability to work within a project team
• 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
• Local project coordination and/or project management experience

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