Cedars-Sinai Clinical Research Data Specialist II in Los Angeles, California
As a Clinical Research Data Specialist II, you will manage 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. You must ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Your roles and responsibilities will include:
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.
- BA/BS degree
- ACRP/SoCRA (or equivalent) certification preferred
- Two (2) years minimum experience in related field, or equivalent combination of education and experience
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.