[Remote] Clinical Research Associate (CRA) — CNS Trials | Northeast | 1099 Contract
Note: The job is a remote job and is open to candidates in USA. GeoSera is seeking an experienced Clinical Research Associate to monitor CNS clinical trials. The role focuses on identifying site-level risks, overseeing trial conduct, resolving findings, and ensuring documentation and follow-up meet protocol and regulatory requirements.
Responsibilities
- This opportunity is for a CRA who understands monitoring beyond completing visit reports: identifying site-level risks, maintaining oversight of trial conduct, resolving findings, and ensuring documentation and follow-up meet protocol and applicable regulatory requirements
Skills
- Prior CRA experience in clinical research, with substantial hands-on CNS trial monitoring experience
- Experience conducting site initiation, routine monitoring, and close-out activities, as applicable to assigned studies
- Working knowledge of ICH-GCP, protocol compliance, informed consent, source data review and verification, essential documents, and site oversight
- Demonstrated ability to identify, document, escalate, and follow through on site issues and monitoring findings
- Experience with clinical trial management systems (CTMS), electronic trial master files (eTMF), and electronic data capture (EDC) systems relevant to previous assignments
- Ability to work under an independent 1099 contractor arrangement
- Include monitoring experience, CNS indications, trial phases, study types, sponsor/CRO experience, geographic coverage, and dates of relevant assignments
- Identify the CNS indications and studies supported, your monitoring responsibilities, and the nature of your site oversight
- Provide two or three specific examples of professional results, such as resolving recurring site findings, improving follow-up timelines, addressing protocol deviations, supporting inspection readiness, or managing challenging sites. Include measurable outcomes where available
- List relevant CTMS, EDC, eTMF, and other monitoring systems, along with your practical level of proficiency
- Provide two relevant professional references who can verify your CRA performance and CNS trial experience
Company Overview
- GeoSera provides clinical operations, project management, data management, medical writing, and site management services for drug trials. It was founded in 2016, and is headquartered in Berwyn, Pennsylvania, USA, with a workforce of 11-50 employees. Its website is https://geosera.com.
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