Note: The job is a remote job and is open to candidates in USA. HiRO is hiring a Senior Clinical Research Associate to monitor and manage sites for Phase I–IV clinical research projects. The role ensures studies are conducted and documented in compliance with protocols, SOPs, ICH-GCP, and applicable regulations, while supporting site performance, data quality, and audit readiness.

Responsibilities

• Performs on-site site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and protocol compliance
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
• Verifies site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan
• Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
• Must be able to quickly adapt to changing priorities to achieve goals / targets
• Prepares for and attends Investigator Meetings and/or sponsor in person meetings
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

Skills

• Minimum of 4 years of independent monitoring experience
• Excellent oral and written communication skills in English, including proficient presentation skills required
• Excellent communication, collaboration, and problem-solving skills
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Demonstrate good computer skills and be able to embrace new technologies
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Oncology and/or Endocrinology experience prioritized

Benefits

• A dynamic and innovative workplace that embraces new ideas.
• Supportive colleagues that are driven by their passion for our mission.
• Opportunities for accelerated career advancement as the team grows.
• Comprehensive benefits package including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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