Clinical Research Associate I - Hitchins Lab - Center for Bioinformatics and Functional Genomics

Are you a passionate and dedicated research professional?

The Cedars-Sinai Center for Bioinformatics and Functional Genomics (CBFG) is an integrated, interdisciplinary research group established in 2016, with the common goal of developing end-to-end research workflows for genomic and high-throughput functional analysis of patient samples.

The Hitchins Laboratory undertakes translational cancer research with a focus on genetic and epigenetic alterations associated with cancer, in particular cancer-specific changes in DNA methylation.

Researchers in the Hitchins Lab undertake studies on genetic and epigenetic alterations that predispose to cancer onset, as well as the discovery and development of epigenetic alterations to serve as tumor biomarkers for applications to cancer diagnosis, prognosis or prediction of treatment outcomes.

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The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination / implementation of noncomplex research studies.

Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

Primary Duties and Responsibilities :

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination / implementation of noncomplex research studies.
• Collects, evaluates and / or abstracts clinical research data. May assist in designing forms for data collection / abstraction.

Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

• Completes Case Report Forms (CRFs).
• Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures.

Provides supervised patient contact or independent patient contact for long term follow-up patients only.

• Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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.

May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Department-Specific Responsibilities :

• Assists with data searches and related administrative tasks.
• Verifies specimen identification and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
• Identifies patients and patient samples by strict adherence to established procedures; Labels samples accurately and completely.
• Reports test results to appropriate individuals and exercise professional discretion with patient information.
• Safe transportation of patient samples from clinic to laboratory.
• Assists with lab-based sample processing, freezing, and inventory.
• Data entry into a relational research database.
• Attends research meetings.
• Maintains organized paper and electronic research files.

Education :

High School Diploma / GED, is required. Bachelor's degree preferred.

Experience and Skills :

• One (1) year of clinical research related experience is preferred.
• Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
• Ability to convey and / or receive written / verbal information to / from various audiences in different formats.
• Computer skills, including Word and Excel, and ability to use standard office equipment is required.
5 days ago