JOB SUMMARY:
The Clinical Research Data Specialist I 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Manages data for research studies.
- Designs forms for data collection.
- Performs clinical data collection/abstraction.
- 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.
- 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.
- 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.

DEPARTMENT SPECIFIC JOB SUMMARY:

Our team includes clinicians, biostatisticians and bioinformaticians focused on high impact cardiovascular clinical research. As a Clinical Research Data Specialist I, you will manage the data for assigned research studies. This will include, designing pipelines for data collection, clinical data abstraction, processing data, maintaining record systems, and producing project reports for studies. Desired skills for processing medical imaging data include proficiency with Python and applicable packages, including OpenCV, Pydicom, SciPy, and PyTorch.

Additional responsibilities include the opportunity to participate in making strategic data-related decisions by analyzing and manipulating data and building models to assist in the clinical and operational setting. Create database-to-deployment pipelines for models using the necessary programming languages (primarily R, Python, SQL). Create sustainable data science infrastructure and adhere to data analysis/machine learning best practices. Perform exploratory data analysis to gauge the need for or appropriateness of advanced analytical methods. Work with business partners to identify areas where data science can best deliver value. Test and validate code to ensure the robustness of data applications. Act as an advisor or thought partner to stakeholders by identifying issues for resolution, providing research expertise and summarizing findings. Collaborate to problem solve and make decisions to achieve desired outcomes. Establish effective working relationships with cross-functional team(s).

DEPARTMENT SPECIFIC JOB DUTIES AND RESPONSIBILITIES:

• Analysis of research data using PyTorch, Scipy, and applicable analysis applications and packages
• Participate in publications and presentations as an author.
• Designs and performs experiments with colleagues and collaborators
• Participates in required training and education programs regarding protecting patient data, best practices with research integrity and applicable laws.

Education:

Bachelor of Arts
OR
Bachelor of Science
OR
Equivalent combination of education and experience
Preferred Degrees: Computer Science, Electrical Engineering, Physics, Math, Economics, Statistics, or equivalent

Experience:

• Essential skills include proficiency using Python, R, and SQL, including PyTorch, Tensorflow, and Scipy. CUDA experience desirable but not essential.
• Relevant background experience includes clinical and / or statistical training or work experience.
• In conjunction with a biostatistician, may perform complex statistical analysis for publication.

Physical Demand:

- Able to perform moderate lifting.
- Able to sit, stand and walk for prolonged periods of time.
- Able to read papers and online documents.
- Able to operate standard office equipment.
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.