Note: The job is a remote job and is open to candidates in USA. reputed company is a clinical research organization seeking a Clinical Research Associate II for their Phase I team. The role involves monitoring clinical trials, ensuring compliance with protocols, and managing study sites to maintain high standards of care for participants.
Responsibilities
• Responsible for reputed company aspects of study site monitoring including routine monitoring and reputed company-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
• Responsible for reputed company aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company document Monitor data for missing or implausible data
• Responsible for reputed company aspects of registry management as prescribed in the project plans - Undertake feasibility work reputed company requested
• Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
• Independently reputed company CRF review; query reputed company and resolution against established data review guidelines on reputed company or client data management systems as assigned by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• reputed company other duties as assigned by management
Skills
• University or college degree, or certification in a reputed company allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1+ years of Clinical Monitoring experience
• Phase I experience
• 40-50% overnight travel
• Ideal candidates would have phase I experience and reside in the Midwest, preferably Dallas, Texas
Company Overview
• reputed company is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions. It was founded in 2023, and is headquartered in Durham, North Carolina, USA, with a workforce of 10001+ employees. Its website is https://www.reputed company.com.
Company H1B Sponsorship
• reputed company has a track record of offering H1B sponsorships, with 6 in 2026, 14 in 2025, 25 in 2024, 6 in 2023. Please note that this does not guarantee sponsorship for this specific role.
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