Heart Institute - Clinical Research Data Specialist III
About The Position
The Clinical Research Data Specialist III manages data for assigned research studies at a senior level. The role designs data-collection forms, abstracts and processes clinical data, maintains record systems, and prepares study reports. It may supervise clinical research staff or clinical data managers, perform complex statistical analysis in conjunction with a biostatistician, and collaborate with bioinformatics on clinical trial management and validation systems. The specialist independently manages complex, large computerized research records to ensure data accuracy, integrity, and security, and helps ensure compliance with federal and local requirements, including FDA and Institutional Review Board requirements. The role supports research at the Smidt Heart Institute, which provides comprehensive heart care and advances cardiovascular research and innovation.
Requirements
- Bachelor's degree (BA/BS) in a related research field.
- Four years of experience in a related research field.
Nice To Haves
- Certification in Clinical Research; ACRP/SoCRA or equivalent certification is preferred.
Responsibilities
- Design forms for research data collection.
- Collect, abstract, process, clean, and manage clinical data, including performing targeted data searches to support study objectives.
- Independently maintain complex, large computerized research records, ensuring data accuracy, integrity, and security.
- Maintain research record systems and perform related administrative tasks.
- Prepare project reports and, with a biostatistician, perform and interpret statistical analyses and present findings to support study objectives and data quality initiatives.
- Supervise clinical research staff or clinical data managers.
- Resolve operational and data problems in consultation with employees or supervisors.
- Collaborate with bioinformatics on the development and maintenance of clinical trial management systems, including system validation.
- Train clinical research staff on data-collection standards, protocol requirements, and data-entry systems.
- Ensure compliance with federal and local agencies and requirements, including FDA and local Institutional Review Board requirements.
- Maintain research practices in accordance with Good Clinical Practice guidelines.
- Protect patient confidentiality in accordance with HIPAA regulations and applicable law.
- Participate in required training and education programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
