Operations Associate, Clinical Assessment Technologies

Requisition Number: 1068

Position Title: Operations Associate, Clinical Assessment Technologies

External Description:

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). 
 
RESPONSIBILITIES:
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

 
OTHER SKILLS AND ABILITIES:

• 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.

 #LI-HD1

City:

State: Kosovo-Metohija

Employment Type: Regular

Community / Marketing Title: Operations Associate, Clinical Assessment Technologies

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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