Operations Associate

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Job Details: Operations Associate

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Operations Associate
SUMMARY: The Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, workbook/source document, for Worldwide Clinical Trials, Inc. (WCT). The Operations Associate is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH/GCP/regulatory guidelines. The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies (CAT). 
Tasks may include but are not limited to:
  • Track the collection, entry, and distribution of rater experience qualification data
  • Review and may develop study specific rater training web portal specifications for portal readiness
  • Assist in coordinating logistical matters and prepare materials for Investigators’ Meetings, which Associate may attend
  • Edit / format materials such as for rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word 
  • Conduct scale management activities, such as  obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
  • Track incoming source documentation to ensure timeliness of source reviews and provide data to the Sponsor and study team
  • Communicate with research sites to ensure rater training and data surveillance plan guidelines are followed
  • Provide CAT data for the CAT Final Study Report completion and ensure proper formatting of document 
    Other Clinical Assessment Responsibilities
  • Assist Operations Manager to ensure budgetary demands are met per CAT project
  • Conduct CAT study material archiving
Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
  • Highly organized, detail- and service-oriented
  • Meets timelines consistently and be able to effectively work under pressure
  • Continuously open to constructive, developmental feedback
  • Skilled in written and verbal communication in order to clearly and concisely present information
  • High level of interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Able to manage multiple tasks and many administrative details in a fast-paced and constantly changing environment
  • High level of self-motivation skills
  • High level ability to work in teams
  • Excellent proficiency in all MS-Office applications, including Microsoft Word, Adobe, Excel, and PowerPoint 
  • Preferred minimum of Associates degree
  • At least 1+ years clinical trial experience
  • Demonstrable knowledge of operational aspects Phase I-IV clinical
  • Ample knowledge of SOPs and ICH/GCP/regulatory guidelines   
  • Competency working with data and numbers
  • Fluency in English (will be required to write, speak and understand English to conduct day-to-day business) 
  • The role requires travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
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