Scientific Research Associate
Há 2 dias
The Clinical Research Associate is responsible for conducting site visits, monitoring data quality and patient safety, and ensuring compliance with ICH-GCP guidelines and local regulations.
The CRA will build and maintain relationships with key site personnel, provide protocol and related study training, and attend disease indication and/or project specific training as required.
Additionally, the CRA will track metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues. They will also communicate site performance to the Clinical Study Team (CST).
Required Skills and QualificationsEssential functions of the job include:
- Completing required elements of the CRA training program and meeting all outlined deadlines
- Performing and coordinating assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
The ideal candidate will have:
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
The Clinical Research Associate will work closely with the CST and clinical study sites to ensure timely delivery of study milestones. They will also assist with other assigned clinical responsibilities within scope of the role.
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