Job Abstract

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) Research Associate will work with a team of other HBCD Research Associates and scientists to support neurocognitive research efforts and use neuroimaging methods in research studies. The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• 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-Specific Responsibilities:

• 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.

Education:

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

Licenses/Certifications:

• 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 required.
• 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.