Company Description
ClinLia is a Saudi-based Clinical Research Organization (CRO) with extensive experience in offering clinical research support and management services. Specialized in a wide range of therapeutic areas, ClinLia aligns its efforts with Saudi Arabia's Vision 2030 to advance clinical research and innovation. The organization's mission is to establish Saudi Arabia as a prominent hub for clinical trials on the global stage.
Role Description
- Follow up on procurement, inventory management, and maintenance of laboratory supplies and equipment, including tracking of calibration certificates.
- ·Liaise with internal and external stakeholders, including sponsors, monitors, Principal Investigators, study teams, and research participants, to ensure smooth study operations.
- Oversee and follow up on the completion of pre-screening logs and coordinate with other physicians or referral sources as needed.
- Support the consenting process, registration, and visit coordination for research participants in compliance with protocol guidelines.
- Coordinate with Principal Investigators (PIs) and Clinical Research Coordinators (CRCs) to ensure timely and accurate collection of primary data, completion of study questionnaires, and data entry into designated clinical trial portals in accordance with protocol.
- Monitor the processing and international shipment of biospecimens to central laboratories, ensuring compliance with hazard safety protocols.
- Ensure timely reporting of adverse events and submission of quarterly SUSAR (Suspected Unexpected Adverse Reaction) and QSUR (Quarterly Safety Update Report) in accordance with regulatory requirements and standard operating procedures (SOPs).
- Maintain accurate and up-to-date documentation including source documents, investigator files, patient files, and records of protocol amendments.
- Assist Clinical Research Associates (CRAs) during monitoring and audit visits by ensuring readiness and availability of required documentation and resources.
Qualifications
- B.S in biology, biochemistry, chemistry, laboratory sciences or equivalent
- Excellent English and computer skills
- Excellent knowledge of ICH GCP requirements
