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The Clinical Research Coordinator I (CRC I) is responsible for assisting with the day-to-day activities of clinical research studies under the supervision of the Principal Investigator (PI) or Clinical Research Nurse and in accordance with Good Clinical Practice (GCP) guidelines FDA regulations and institutional policies. The CRC I is responsible for assisting with study operations participant recruitment and data management contributing to the overall success of clinical trials. This is an entry-level role for individuals seeking to develop their career in clinical research.
#CB
Program Management
in the coordination of clinical research studies including study start-up execution and close-out activities.
all study activities are conducted in compliance with the study protocol GCP and relevant regulatory guidelines.
recruit and enroll study participants according to the inclusion/exclusion criteria outlined in study protocols and as instructed by the PI.
informed consent from study participants and ensure their understanding of study procedures.
basic clinical assessments such as taking vitals and or administering questionnaires.
information and support to participants throughout the study period.
Job Quality
collect record and maintain study data in case report forms (CRFs) or electronic systems.
and process biological samples such as blood urine or tissue following proper clinical and laboratory procedures.
and report any adverse events deviations or protocol violations in a timely manner.
patient visits follow-ups and schedule necessary procedures and tests according to protocol.
the safety of participants by following established safety protocols and guidelines.
study visits and assessments according to study protocols.
Collaboration and Partnership
open communication with the PI clinical research team and external study sponsors.
regular updates to the research team regarding study progress recruitment and any issues encountered.
as the main point of contact between study participants and the research team ensuring clear communication of study procedures and addressing participant concerns.
in study meetings with the research team and investigators and provide updates and contribute to problem solving discussions.
with the completion of study close-out activities including final study visits and data reconciliation.
industry-sponsored trials the CRC I may interact with study sponsors or Contract Research Organizations (CROs) and be required to participate in monitoring visits and data audits checks.
Other duties as assigned.
Required Experience:
IC
Full-Time