Clinical Operations Specialist
hace 4 semanas
**About the Role**
Worldwide Clinical Trials is seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team. As a Clinical Operations Specialist, you will be responsible for carrying out daily aspects of operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document management.
**Key Responsibilities**
Track the collection, entry, and distribution of rater experience qualification data
Review and develop study-specific rater training web portal specifications for portal readiness
Assist in coordinating logistical matters and prepare materials for Investigators' Meetings, which you may attend
Edit/format materials such as 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
**Requirements**
Highly organized, detail-oriented, 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
**Preferred Qualifications**
Preferred minimum of Associate's 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.
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