PROMETRIKA, LLC

Clinical Research

• Ensure the rights and well-being of human subjects are protected and trial data are accurate, complete, and verifiable
• Oversee overall trial conduct at assigned study sites and ensure compliance with SOPs, ICH, GCP, regulations, company goals, and budgets
• Oversee and track study monitoring activities, including CRA selection and management, trip report review, and monitoring/co-monitoring visits
• Contribute to protocols, consent forms, CRFs, study manuals, monitoring plans, training materials, and other key study documents
• Participate in vendor selection, qualification, and management
• Conduct quality risk assessments, develop KRIs, and support risk management activities
• Manage sites, including training, data-query resolution, monitoring findings, enrollment tracking, informed-consent compliance, IP accountability, supplies, and protocol-deviation reporting
• Resolve site performance issues and recommend and track CAPAs
• Perform site qualification, initiation, routine monitoring, and close-out visits
• Perform remote and centralized monitoring and aggregate site/study data review
• Develop and maintain clinical study files and support eTMF reconciliation
• Assist with SAE case-management reconciliation
• Maintain study tracking in CTMS or other tools
• Report site updates and project risks to the Clinical Trial Manager and/or Lead CRA
• Support grant reconciliations, clinical study report quality checks, and safety-narrative drafting
• Meet department KPIs and propose improvements
• Attend project meetings and teleconferences and potentially present at Investigator Meetings
• Support site audits and inspections and respond to identified issues
• Maintain scientific knowledge in the project therapeutic area
• Maintain effective communication among sites, clinical teams, and sponsors
• Contribute to SOPs, manuals, templates, budgets, proposals, client materials, and process initiatives
• Participate in business development, recruiting, hiring, thought leadership, and knowledge-sharing activities
• Train junior CRAs, lead team trainings, support contract CRA onboarding and management, and participate in resource assignments
• Perform other duties as required

Explore Senior Clinical Research Associate at PROMETRIKA, LLC. Review requirements and application details.

Open roles

Senior Clinical Research Associate