Clinical Research Data Specialist II - Butte Lab - Department of Neurosurgery

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The primary focus of the Butte Laboratory is translational research in the field of bio-photonics. The Butte Lab is developing novel intra-operative imaging/visualization technologies to aid surgeons in achieving near-complete tumor excision. To learn more about the Butte Lab, please visit this website.

About the Role

The Clinical Research Data Specialist II manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. In addition, may supervise clinical research staff or clinical data managers, perform complex statistical analysis, and work with bioinformatics to develop and maintain trial management and validation systems.

Primary Duties and Responsibilities:

• May work with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
• May train clinical research staff to help improve the quality of the data being collected.
• May solve operational/data problems in consultation with other employees and/or supervisors.
• Manages data for research studies.
• Designs forms for data collection.
• Processes clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
• Produces project reports.
• Performs clinical data collection, abstraction, targeted data searches to support accurate and timely data availability for study objectives.
• Maintains the accuracy, integrity and security of complex, large computerized records systems.
• Understands regulations, policies, protocols and procedures to control and maintain accurate records.
• Performs data searches and other related administrative tasks.
• Prepares project reports and performs statistical analysis in conjunction with a biostatistician, interpreting and presenting findings to support study objectives and data quality initiatives.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Education:

• Bachelor's degree in related field of research is required.

Experience:

2 years of proven experience in a similar position or related research field is required.