Principal Research Associate
1 week ago
The Senior Clinical Research Associate will play a pivotal role in overseeing clinical trials, ensuring adherence to regulatory guidelines and protocols. This position requires expertise in site management, including feasibility, start-up, and site close-out activities.
">Key Responsibilities:- Act as a project team member to contribute towards efficient trial management.
- Perform Site Qualification Visits to discuss protocol and study requirements with investigators and trial staff.
- Support feasibility, site selection, and start-up activities, including preparing human research ethics committee submissions with sites.
- Negotiate site budgets and assist with the execution of site contracts with support from project managers.
- Perform Site Initiation Visits to train investigators and trial staff in the protocol and data collection methods.
- Perform Interim Monitoring Visits to ensure adherence to protocol, monitor participant source data, and perform investigational product accountability.
- Oversee all aspects of study site management to ensure high-quality data.
- An undergraduate degree in life sciences (e.g., biology, chemistry, pharmaceuticals).
- At least 3-4 years' experience in monitoring clinical trials in CRO, pharmaceutical, and/or biotechnology industries as a SCRA/CRA.
- Experience in managing early phase oncology trials is highly preferred.
- Experience in EDC & CTMS.
- Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
- Experience in contract negotiation desirable.
- Experience in HREC submission preparation.
- Understanding and practical knowledge of ICH-GCP requirements particularly for site management.
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