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Clinical Site Manager III
Location:
Abee
Description:
Job Description : Can be remote but MUST be located in CA Contract Clinical Research Associate (CRA) Job Summary As a Contract CRA in ophthalmology, you will be responsible for monitoring and managing clinical trials, at the sites under your responsibility, related to eye diseases, ophthalmic treatments, and ophthalmic devices. You will ensure that these trials are conducted in compliance with international guidelines, local regulations, industry standards, and study protocols. This position is regionally based and involves working with multiple clinical trial sites across multiple protocols. Key Responsibilities: 1. Site Selection and Initiation: • Assist in the selection of investigative sites for clinical trials. • Conduct site initiation visits to verify that site staff are properly trained and delegated to perform protocol backssments, are familiar with regulatory requirements, and understand proper handling and storage of ophthalmic drugs / devices. • Ensure recruitment strategies are in place to meet enrollment targets. • Confirm that site meets requirements to begin screening subjects. 2. Monitoring and Site Management: • Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance. • Review source documents, case report forms, and patient records. • Verify the informed consent process is properly executed and adherence to the study protocol. • Ensure that instruments / equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards. • Collaborate with Clinical Operations Lead and Clinical Trial Team (CTT) to identify and resolve site quality or study execution issues. 3. Regulatory Compliance: • Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e. g. FDA, ICH, GCP, ISO) regarding ophthalmic drugs / devices. • Ensure that study sponsor. Visit ListedBuy for more information.
Company:
Aequor
Posted:
December 7 2023 on ListedBuy
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More About this Listing: Clinical Site Manager III
Clinical Site Manager III is a Executive Manager Job at Aequor located in United States. Find other listings like Clinical Site Manager III by searching Oodle for Executive Manager Jobs.
Clinical Site Manager III is a Executive Manager Job at Aequor located in United States. Find other listings like Clinical Site Manager III by searching Oodle for Executive Manager Jobs.