Clinical Research Associate I/CPT - Hitchins Lab - Biomedical Sciences
- Cedars Sinai
- Location: Los Angeles, CA
- Job Number: 7171736 (Ref #: HRC1341769)
- Posting Date: Aug 9, 2023
- Application Deadline: Open Until Filled
Discover more at Cedars-Sinai as a Clinical Research Associate I!
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. To learn more, please visit: Hitchins Lab | Cedars-Sinai.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms (CRFs), entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties & Responsibilities:
- Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
- Provides supervised patient contact or patient contact for long term follow-up patients only.
- Assists 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.
- Schedules patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- 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.
- Supervised recruitment and consenting of eligible/potential patients to minimal-risk studies.
- Participates in required training and education programs including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
- Performs phlebotomy services according to CSMC policies and procedures.
- Verifies specimen identification and takes appropriate action when corrections are indicated.
- Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
- Performs sample processing.
High School Diploma is required. Bachelor's degree preferred in Science, Sociology, or a related field.
Department-Specific Licenses and Certifications:
Phlebotomy Certification CA (CPT-1) is required.
Experience and Skills:
- One (1) year of clinical research experience is preferred. Understanding of general clinical research objectives.
- 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.
Working Title: Clinical Research Associate I/CPT - Hitchins Lab - Biomedical Sciences
Department: BMS - Bioinfo & Func Genomics
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$19.50 - $29.87