Clinical Research Data Specialist II - Barbara Streisand Women Heart Center

• Collaborates with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
• Prepares project reports and performs basic statistical analysis in conjunction with a biostatistician, interpreting and presenting findings to support study objectives and data quality initiatives.
• Identifies and resolves operational/data problems, recommending and implementing process improvement with minimal supervision
• Trains clinical research staff on data collection standards, protocol requirements, and data entry systems to promote accuracy and consistency in research data.
• Independently manages data for research studies, including processing clinical data using a range of computer applications and database systems to support cleaning and management of subject or patient data.
• Performs clinical data collection, abstraction, targeted data searches to support accurate and timely data availability for study objectives.
• Maintains the integrity, security, and confidentiality of large, computerized records systems in compliance with HIPAA and applicable regulations.
• Understands regulations, policies, protocols and procedures to control and maintain accurate records.
• Ensures all data practices comply with federal/local regulations, including FDA, IRB, and Good Clinical Practice (GCP) guidelines.

• Minimum of a Bachelor of Science or Bachelor of Arts degree required.

• Certification in Clinical Research, ACRP/SoCRA (or equivalent) is preferred.

• Two (2) years minimum experience in related field, or equivalent combination of education and experience.

Cedars-Sinai