Clinical Research Data Specialist III - Heart Institute - Bairey-Merz Lab

The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

Are you ready to be a part of breakthrough research?

The Clinical Research Data Specialist III manages the data for assigned research studies at a senior level. 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

• Supervises clinical research staff or clinical data managers.
• Solves operational/data problems in consultation with other employees and/or supervisors.
• In conjunction with a biostatistician, may perform complex statistical analysis for publication.
• Works with bioinformatics in the development and maintenance of clinical trials management systems including validation of systems.
• Trains clinical research staff on data collection standards, protocol requirements, and data entry systems to promote accuracy and consistency in research data.
• Independently manages and maintains research data to ensure accuracy, integrity, and security of complex, large, computerized records systems. This includes performing 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.
• Processes 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.
• Understands regulations, policies, protocols and procedures to control and maintain accurate records .
• 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 BA/BS degree in related field of research required.

Experience:

• 4 years' experience in related field of research required.

Licenses and Certifications:

• Certification In Clinical Research from ACRP/SoCRA (or equivalent) certification preferred.