Monitoring adverse events (AEs) and serious adverse events (SAEs), ensuring timely reporting to sponsors / IRBs.
Entering data into electronic systems (EDC / CTMS), maintaining source documentation, case report forms (CRFs) and regulatory files.
Interacting with sponsors / CROs, coordinating with study monitors, handling queries and managing trial logistics.
Ensuring compliance with Good Clinical Practice (GCP), institutional policies and regulatory requirements.
Often serving as the participant-facing point of contact and maintaining excellent communication and engagement with subjects and site staff.
Why the role matters :
The CRC ensures that the research is conducted ethically, safely, according to protocol, and produces high-quality data.
They maintain the interface between participants, clinical staff, sponsors / CROs and regulatory oversight — which is critical for successful trial execution.
Because they manage many moving parts (visits, documentation, labs, data, adverse events), strong organisational, communication and multitasking skills are essential.
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Clinical Research Coordinator • Dallas, TX, US
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