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 includes designing data-collection forms, abstracting and processing clinical data, maintaining record systems, and producing study reports. The specialist may supervise clinical research staff or clinical data managers, conduct complex statistical analyses, and work with bioinformatics to develop and maintain clinical trial management and validation systems. The role ensures compliance with federal and local agency requirements, including those of the Food and Drug Administration (FDA) and the local Institutional Review Board (IRB), and maintains research practices in accordance with Good Clinical Practice (GCP) guidelines and patient-confidentiality requirements under HIPAA and applicable law.
Requirements
- Bachelor's degree (BA/BS) in a related field of research.
- Four years of experience in a related field of research.
Nice To Haves
- Certification in Clinical Research; ACRP/SoCRA or equivalent certification preferred.
Responsibilities
- Supervise clinical research staff or clinical data managers.
- Resolve operational and data problems in consultation with other employees and/or supervisors.
- In conjunction with a biostatistician, perform complex statistical analysis for publication, as applicable.
- Work with bioinformatics to develop and maintain clinical trials management systems, including system validation.
- Train clinical research staff on data-collection standards, protocol requirements, and data-entry systems to promote accuracy and consistency.
- Independently manage and maintain research data to ensure the accuracy, integrity, and security of complex, large computerized records systems, including performing data searches and related administrative tasks.
- Prepare project reports and perform statistical analysis with a biostatistician; interpret and present findings to support study objectives and data-quality initiatives.
- Process clinical data using computer applications and database systems to support cleaning and management of subject or patient data.
- Collect and abstract clinical data and conduct targeted data searches to support accurate and timely data availability for study objectives.
- Understand and follow regulations, policies, protocols, and procedures for controlling and maintaining accurate records.
- Ensure compliance with federal and local agencies, including the FDA and local IRB.
- Maintain research practices in accordance with GCP guidelines.
- Maintain strict patient confidentiality according to 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
