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.

Preferred minimum of an associate’s degree
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

Operations Associate, Clinical Assessment Technologies

Key skills