Clinical Operations Specialist for Clinical Trials
hace 5 horas
We are seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team at Worldwide Clinical Trials.
About the Role:
The Clinical Operations Specialist will be responsible for ensuring all daily aspects of operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance maintenance, and workbook/source document management are carried out in a timely fashion and in compliance with SOPs and ICH/GCP/regulatory guidelines.
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 preparing materials for Investigators' Meetings
- Edit/format materials such as rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word documents
- 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
Requirements:
- Highly organized, detail-oriented, and service-oriented individual
- Meets timelines consistently and able to effectively work under pressure
- Continuously open to constructive feedback
- Skilled in written and verbal communication to clearly present information
- High level of interpersonal skills in a fast-paced, deadline-oriented environment
- Able to manage multiple tasks and administrative details in a fast-paced environment
- High level of self-motivation and ability to work in teams
Preferred Qualifications:
- Minimum of an Associate's degree
- At least 1+ years of clinical trial experience
- Demonstrable knowledge of operational aspects of Phase I-IV clinical trials
- Ample knowledge of SOPs and ICH/GCP/regulatory guidelines
- Competency working with data and numbers
- Fluency in English (required for day-to-day business)
Estimated Salary: $65,000 - $80,000 per year, depending on location and experience.
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