Cedars-Sinai Clinical Research Data Specialist III - Heart Institute in Los Angeles, California

The Clinical Research Data Specialist III 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 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.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

May supervise clinical research staff or clinical data managers.

In conjunction with a biostatistician, may perform complex statistical analysis for publication.

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.

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.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

May supervise clinical research staff or clinical data managers.

In conjunction with a biostatistician, may perform complex statistical analysis for publication.

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.

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.

DEPARTMENT AND/OR UNIT SPECIFIC – ESSENTIAL JOB RESPONSIBILITIES:

The way we do biomedical science is changing. Given that we can now measure millions of variables per experiment, the next set of great discoveries will be made by researchers who can efficiently sift through large volumes of data and rigorously glean elemental truths. While methods in science are shifting, the fundamental questions remain the same. Therefore, our research collaborative is seeking extremely motivated team members who are skilled at handling and managing high-dimensional datasets that will be analyzed to address clear and relevant questions. Our inter-institutional collaborative applies high-throughput molecular and image-based phenotyping methods in population cohorts to identify key drivers of the balance between healthy aging and the risk for age-related diseases. Our team includes clinicians, biostatisticians, bioinformaticians, epidemiologists, imaging specialists, analytical chemists, and basic biologists – all collectively focused on making discoveries that will profoundly impact human health.

Interested candidates should ideally have experience organizing, managing, and merging large datasets that include numerous exposure measures and longitudinal outcomes. The successful candidate will work closely with a team of scientists to create a comprehensive and harmonized large database resource that will be used by investigators across multiple fields to discover and confirm biomarker relations with disease outcomes. All applicants should have exceptional organization, written, and oral communication skills. All candidates should be highly self-motivated, enthusiastic, and have a desire to work as part of a dynamic and diverse collaborative team in a start-up like environment.

Assumes primary responsibility for high-quality organization, harmonization, integrity, security, and overall management of all research study data.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

Contribute to study design as well as creation and implementation of analytical plans for specific research projects or a set of research projects.

Contribute to the preparation and presentation of research results in the form of oral presentations at meetings and conferences as well as in the form of original research publications.

Coordinate collaborative data analysis related activities with investigators across departments and institutions across the U.S., Europe, and Latin America.

May work with bioinformatics in the development and maintenance of data management systems including validation of systems.

May supervise clinical research staff or clinical data managers.

May train clinical research staff to help improve the quality of the data being collected.

Physical Demands:

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.

Educational Requirements:

BA/BS degree. Undergraduate degree with at least 2 years of highly relevant experience, or Masters or PhD degree preferably in a data management, analytical, and/or computational field.

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Five (5) years minimum experience in related field, or equivalent combination of education and experience.

Experience using SQL, R, STATA, and/or SAS for managing and analyzing large datasets.

Direct experience managing and/or analyzing high-dimensional datasets would be highly valued.

Experience with Python and working in Linux environments would be valued but is not required.

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.