Clinical Research Associate I - Gao Lab - Biomedical Imaging Research Institute
- Cedars Sinai
- Location: Los Angeles, CA
- Job Number: 7171738 (Ref #: HRC1297761)
- Posting Date: Aug 8, 2023
- Application Deadline: Open Until Filled
Do you have a passion for the highest quality and patient happiness? Then please respond to this dynamic opportunity available with one of the best places to work in Southern California! We would be happy to hear from you.
The Cedars-Sinai Biomedical Imaging Research Institute (BIRI) is an interdisciplinary research program established in 2010 to develop and apply state-of-the-art imaging technologies to today’s most pressing translational research and clinical questions. Our mission is to improve the diagnosis, prevention and treatment of diseases by developing novel medical imaging technology. To learn more, please visit Biomedical Imaging Research Institute | Cedars-Sinai
Are you ready to be a part of breakthrough research?
In the Gao Lab under supervision, the Healthy Brain and Child Development (HBCD) Clinical Research Associate I (CRA I) will work with a team of other HBCD CRA I and scientists to support neurocognitive research efforts and use neuroimaging methods in research studies. 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, 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 and Responsibilities:
- Evaluates and abstracts clinical research data from source documents.
- Ensures compliance with protocol and overall clinical research objectives.
- Completes Case Report Forms (CRFs).
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- 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.
- Assists with 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.
- Recruitment and retention of research subjects, and coordination of subject appointments with facilities and staff.
- Data collection with infants/children and their parent/guardian (including MRI, EEG, behavioral, and biospecimen data).
- Collecting and storing biological samples.
- Administration of diagnostic interviews acquiring confidential and sensitive information including substance use during pregnancy and medical/mental health history.
- Administration of neuro-cognitive assessments and symptom rating scales (training will be provided).
- Conducting EEG beginning in infancy (training will be provided)
- Maintaining of accurate and complete clinical research files, updating study databases, and ensuring compliance with standardized protocols.
- Performing other duties as needed including assisting with annual IRB and NIH reporting.
- Develop and maintain a detailed follow-up log for assessing participant progress.
- Maintaining communication with the HBCD consortium.
High School Diploma/GED is required. Bachelor's degree preferred.
- ACRP/SoCRA (or equivalent) certification is preferred.
- Certified Phlebotomy Technician I (CPT I) upon hire.
Experience and Skills:
- One (1) year minimum of directly related experience is preferred.
- Bilingual in Spanish is preferred.
- Establishes effective working relationships with cross-functional team(s).
- Ability to use discretion and maintain privacy, confidentiality or anonymity.
- 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 - Gao Lab - Biomedical Imaging Research Institute
Department: BMS - BioMed Imaging Res Inst
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