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Operations Associate / Assistant

Posted on Mar 15, 2019 by Worldwide Clinical Trials

Not Specified Serbia
Research & Development
13 Mar 2019
Annual Salary
Full-Time
Join us at Worldwide as an Operations Assistant and be part of something that makes that difference!

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. 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 and regulatory guidelines. The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies .

RESPONSIBILITIES:

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 and 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

OTHER SKILLS AND ABILITIES:

Highly organised, 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
Excellent proficiency in all MS Office applications, including Microsoft Word, Adobe, Excel, and PowerPoint

REQUIREMENTS:

Preferred minimum of Associates degree
Demonstrated clinical trial experience
Demonstrable knowledge of operational aspects Phase I to IV clinical
Ample knowledge of SOPs and ICH or GCP and or regulatory guidelines
Competency working with data and numbers
Fluency in English
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.

Reference: 671078569