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Cedars-Sinai Clinical Research Coordinator - Neuro-Imaging Program - BIRI in Los Angeles, California

The Neuro-Imaging program at

the Biomedical Imaging Research Institute (BIRI) of Cedars-Sinai Medical Center

has an open position for a talented Clinical Research Coordinator II (CRC II). The

primary responsibility of this position is to help the recruitment and

retention of pediatric subjects for a nation-wide, multi-site study of early

brain and behavioral development in infants and children. This position is

highly rewarding as the Clinical Research Coordinator II has the opportunity to

participate in one of the nation’s largest scale studies of developing and

at-risk children exposed to drugs during pregnancy. The research findings may

inform better strategies moving forward to help those exposed to risks during

development.

This position involves

delicate coordination and communication between our imaging department, the

OBGYN department, the Neonatal intensive care unit (NICU), substance use

disorder treatment centers, and most importantly, the candidate moms and

children. Therefore, strong inter-personal skills and highly effective

communication capabilities with not only researchers but also participating

moms and families, are a must for this position. The successful CRC II will

require sensitivity to low-income families with substance use disorders, the

ability to be empathetic to participants, and the ability to build trustworthy

relationships. Beyond research coordination, the CRC II will participate in

behavioral/environmental assessment of infants. Overall, consider this position

as a highly challenging but also a highly rewarding opportunity to help those

at-risk and vulnerable infants and children to reach their best potential

through dedicated research using advanced imaging (i.e., Magnetic Resonance Imaging

(MRI)) and behavioral assessment methods. Therefore, passion in developmental

research and children in general will be essential to be successful in this

position.

JOB SUMMARY:

The Clinical Research Coordinator I works independently

providing study coordination including screening of potential research

participants 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 this

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).

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Independent study coordination including screening of

potential research participants for protocol eligibility, presenting

non-medical trial concepts and details to the research participants, and

participating in the informed consent process.

Scheduling of research participants 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 research participant condition, adverse events, concomitant

medication use, protocol compliance, response to study drug.

Schedules and participates in monitoring and auditing

activities.

Notifies direct supervisor about concerns regarding data

quality and study conduct.

Independently works with external study monitors and/or

auditors.

Works closely with a regulatory coordinator or directly with

the Institutional Review Board (IRB) to submit initial applications,

amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol

deviations, and Safety Letters in accordance with local and federal guidelines.

May involve other regulatory / Institutional Review Board

duties, budgeting duties, and assisting with research participant

billing and reconciliation.

May supervise Clinical Research Associates on data entry,

data query and resolution.

Maintains research practices using Good Clinical Practice

(GCP) guidelines.

Maintains strict research participant confidentiality

according to HIPAA regulations and applicable law.

Educational Requirements:

BA/BS Degree

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Two (2) years of directly related experience, 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.

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