Description
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
Job Summary
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 train clinical research staff, perform basic statistical analysis, and work with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
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.
- May perform basic statistical analysis in conjunction with a biostatistician.
- 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.
- Participates in required training and education programs.
Qualifications
- BA/BS degree required.
- Two (2) years minimum experience in related field, or equivalent combination of education and experience.
