Clinical Research Coordinator
1 week ago
The Clinical Research Coordinator ("CRC") comprises an integral part of the research team at the Sites level.
Working in coordination with the Principal Investigator, he/she is responsible to support the Principal Investigator in conducting the Study in accordance with ICH-GCP, regulatory standards, Protocol study design and client standards.
Depending on departmental organization, the CRC may also have responsibility for helping the Principal Investigator to look for potential patients in the medical records, maintain updated the Case Report Form, the Tracking Logs, the Investigator Study File and all the Ethics and Regulatory paperwork.
CRCs may also support and advise patients giving their consent for participation in the Study and motivate patient to continue in the Study during its integral duration.
Responsibilities:
- Preparing for study initiation;
- Obtaining physician signatures;
- Support identifying potential Patients for the Study;
- Ensure Completing case report forms ("CRF") as per timelines;
- Ensure Protocol Deviation documentation is as per GCP and Protocol requirement's;
- Maintaining tracking logs and study files;
- Submitting ethical and regulatory documents to IRB;
- Submitting the clinical study agreement for review;
- Attending investigator meeting(s);
- Maintaining studyspecific supplies;
- Preparing for study closure and archiving.
Minimum requirements:
- Education background: pharmacy or life science background
- Years of experience : 13 years
- Technical skills: clinical research, Trials guidelines
- Experience in clinical research
- Languages: English and Arabic speaking
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
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