Clinical Research Coordinator, I
Company: MemorialCare
Location: Fountain Valley
Posted on: April 6, 2021
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Job Description:
Under direct supervision of the Director of Clinical Operations,
Manager of Clinical Operations and principal investigator, the CRC
I is responsible for enlisting, maintaining, and assuring protocol
compliance for all study participants in clinical trials.
Responsibilities Collaborates with study investigator in
determining eligibility of potential participants in clinical
trials Screens potential participants for protocol eligibility.
Presents trial concepts and details to the participant,
participates in the informed consent process, and enrolls
participants in study protocol Ensures research quality by
practicing in compliance with Standard Operating Procedures (SOP),
principles of Good Clinical Practice (GCP) and applicable federal,
state, and local regulations. Coordinates patient care in
compliance with protocol requirements. May disburse investigational
drug and provide participants' education regarding medication
administration. Maintains investigational drug accountability, when
needed, in cases where the Research Pharmacy is not maintaining
that responsibility. In collaboration with the study investigator,
reviews study participants for changes in conditions adverse
events, concomitant medication use, protocol compliance, response
to study drug and thoroughly documents all findings. Responsible
for accurate and timely data collection, documentation, entry, and
reporting. Schedules and participates in monitoring and auditing
activities. Maintains current and accurate documentation in the
regulatory binder(s) as required by
regulations and sponsors. Participates in required training and
education programs. Provides a safe environment for study
participants, caregivers, and study personnel at all times through
compliance with all federal, state, and professional regulatory
standards. Maintains strict patient confidentiality according to
HIPAA regulations and applicable law. Participates in the
after-hours support and coverage schedule, if necessary. Be at work
and be on time. Interacts in a positive and constructive manner.
Follows company policies, procedures and directives . To use the
power of the collective voice to improve global health and
wellbeing through informed investments and policies Learn more
.
Keywords: MemorialCare, Fountain Valley , Clinical Research Coordinator, I, Healthcare , Fountain Valley, California
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