Clinical Research

• Lead the planning, execution, and oversight of assigned clinical studies from study start-up through closeout, ensuring compliance with Good Clinical Practices (GCP), ICH guidelines, applicable regulatory requirements, study protocols, and company SOPs.
• Partner cross-functionally with Medical Affairs, Data Management, Clinical Operations, Regulatory Affairs, Client Services, Finance, Legal, and external vendors to achieve study objectives and timelines.
• Oversee and manage CROs, vendors, and investigational sites, including oversight visits, site payment management, and review and approval of monitoring visit reports, as applicable.
• Manage study timelines, enrollment metrics, vendor performance metrics, study budgets, and vendor payments.
• Proactively identify operational risks, enrollment challenges, and execution barriers, implementing mitigation strategies to ensure successful study completion.
• Collaborate with Legal and investigational sites to support contract and budget negotiations and ensure study activities remain within approved scope and financial objectives.
• Lead study team meetings and provide regular updates to stakeholders and senior management on study progress, risks, and key milestones.
• Contribute to the development and review of study-related documents, including protocols, informed consent forms, laboratory manuals, study plans, site training materials, and SOPs.
• Support data review, database lock activities, clinical study reports, regulatory submissions, inspections, and audit readiness efforts.
• Ensure appropriate site training and ongoing support to investigators and study personnel, promoting protocol compliance and high-quality study conduct.
• Oversee sample management activities and coordinate closely with Clinical Operations to ensure timely and accurate processing of study specimens.
• Review and approve study-related invoices and expenditures, ensuring alignment with approved budgets and financial goals.

Clinical Trial Manager

• Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies
• Performs a variety of complex activities to appropriately compile, document and analyze clinical research data
• Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol
• Protect the rights and the well-being of subjects enrolled in studies
• Ensures thorough, individualized, protocol-based study subject education on all study process requirements
• Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI
• Accurately documents study subject activities as outlined by the protocol

Clinical Research jobs in Colorado

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Clinical Trial Manager

Clinical Research Coordinator II