Posted in Other 30+ days ago.
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Type: Full Time
Location: Durham, North Carolina
RTI International s Clinical Research Informatics Program is seeking a Clinical Data Associate to assist with the collection, management, and processing of data for a variety of multi-site research networks. The Clinical Data Associate will work collaboratively as part of a multidisciplinary team to develop, test and manage research data and systems using a variety of off-the-shelf products and in-house software applications. Responsibilities include supporting the lead data manager by performing all data management activities on one or more clinical trial projects, monitoring and liaising with the clinical sites as required, and keeping the team informed of study issues and progress.
* Assist in designing Case Report Forms (CRFs) and eCRFs and annotating for data acquisition and data entry
* Developing test cases and performing user acceptance testing of Electronic Data Capture (EDC) systems
* Assist in developing training materials, project documentation, Good Clinical Practice (GCP) materials
* Performing QC review of the data and coordinating timely corrections to the database with the clinical sites
* Monitoring study metrics and site performance using standard study management tools
* Assist in establishing data and work flow plans
Education and Experience:
* Bachelor's degree
* A combination of performance, education and prior work experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
* Ability to learn and use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools as projects require
* Strong IT skills, including excellent knowledge of various software programs and packages including MS PowerPoint, MS Word, Excel
* Ability to work effectively both as part of a project team and independently is essential
* Excellent oral and written communication skills in English.
* Proven experience providing project and data management support on FDA regulated studies, complex multi-site studies or data coordinating center projects
* Proven experience using data management systems such as Medidata RAVE and/or REDCap tools and processes to support multi-site, multi-mode research studies
* Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs and client expectations
* Good organizational and analytical/problem-solving skills with strong attention to detail
* Ability to work productively with minimal supervision
* Strong customer focus and excellent interpersonal skills
* Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.