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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