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Clinical Operations Associate
hace 2 meses
We are seeking a highly organized and detail-oriented Clinical Operations Associate to join our team at Worldwide Clinical Trials. As a key member of our Clinical Assessment Technologies group, you will play a critical role in ensuring the successful execution of clinical trials.
Key Responsibilities- Track and manage rater experience qualification data, ensuring timely collection, entry, and distribution.
- Develop and review study-specific rater training web portal specifications to ensure portal readiness.
- Coordinate logistical matters and prepare materials for Investigators' Meetings, which may include attending the meetings.
- Edit and format materials such as rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word.
- Conduct scale management activities, including obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals.
- Track incoming source documentation to ensure timely 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.
- Perform other duties as assigned, including assisting the Operations Manager in ensuring budgetary demands are met per CAT project and conducting CAT study material archiving.
- Highly organized, detail-oriented, and service-oriented individual with excellent communication skills.
- Ability to meet timelines consistently and work effectively under pressure.
- Continuous openness to constructive feedback and a high level of interpersonal skills in a fast-paced, deadline-oriented environment.
- Ability to manage multiple tasks and administrative details in a fast-paced and constantly changing environment.
- High level of self-motivation and ability to work in teams.
- Preferred minimum of Associate's degree and at least 1+ years of clinical trial experience.
- Demonstrable knowledge of operational aspects of Phase I-IV clinical trials, SOPs, and ICH/GCP/regulatory guidelines.
- Competency working with data and numbers, and fluency in English (required for writing, speaking, and understanding).
Worldwide Clinical Trials is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality. Our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases enables us to develop flexible plans and solve problems quickly for our customers.
We are united in our cause to improve the lives of patients through new and innovative therapies. Our talented team of 3,000+ professionals spans 60+ countries, and we prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
