Operations Associate, Clinical Assessment Technologies - U.S.

Worldwide Clinical Trials•Durham, NC

About The Position

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 Standard Operating Procedure (SOP)s and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP)/regulatory guidelines. The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies (CAT).

Requirements

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
Minimum 1+ year clinical trial experience
Demonstrable knowledge of operational aspects of 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 to attend key meetings
The global nature of the position may also require the incumbent to occasionally manage their time flexibly to be responsive to stakeholders in different time zones

Nice To Haves

Preferred minimum of an associate’s degree

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 the 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 the document
Assist the Operations Manager to ensure budgetary demands are met per the 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.