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
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
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
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
Notifies direct supervisor about concerns regarding data
quality and study conduct.
Independently works with external study monitors and/or
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
Maintains strict research participant confidentiality
according to HIPAA regulations and applicable law.
ACRP/SoCRA (or equivalent) certification preferred.
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.