Clinical Research

• Serve as the main point of contact for assigned protocols and link Country Operations with clinical trial teams
• Plan, drive and track study deliverables, timelines and results from feasibility and site selection through recruitment, execution and closeout
• Ensure protocol performance complies with ICH/GCP, country regulations, company policies, quality standards and adverse event reporting requirements
• Review Monitoring Visit Reports and escalate performance issues and training needs
• Perform quality control visits as required
• Lead local study teams, train local roles, support CRAs as protocol expert and coordinate country activities
• Create and execute local risk management plans for assigned studies
• Ensure compliance with CTMS, eTMF and other key systems
• Escalate study challenges and issues to appropriate clinical operations and trial-team leadership
• Identify and share best practices
• Collaborate with vendors, investigators and external partners
• Build business relationships with investigators and represent the company
• Support local and regional strategy development
• Collaborate with headquarters, regional and local operations, clinical development, pharmacovigilance, regulatory affairs, medical and scientific affairs teams

Manager, Clinical Research

• Conduct source data verification and ensure clinical trial data is submitted to data management promptly
• Identify study conduct issues and ensure appropriate closure
• Manage investigator site workload to run studies efficiently and meet objectives
• Ensure studies comply with ICH/GCP, local laws, and client SOPs
• Maintain patient safety and report safety issues according to regulatory requirements
• Inform principal investigators and site staff of issues
• Develop corrective and preventive actions with investigators and site personnel
• Manage sites from selection through study closeout
• Train site staff on protocols, amendments, and client processes
• Maintain sufficient knowledge of the product, protocol, and therapy area
• Interact with healthcare professionals and support client credibility
• Ensure monitored data meets quality standards and is entered into client systems promptly
• Report study progress after site visits and catalog and close issues
• Maintain accurate site-level clinical trial registry information
• Obtain and maintain Investigator Initiation Package, Site Master File, ELARA, and/or Trial Master File documentation
• Quality-control relevant documents and maintain monitoring logs
• Generate site monitoring reports
• Complete required training, timesheets, expense reports, and CV updates
• Comply with Parexel processes, ICH-GCP, and applicable requirements

Clinical Research Associate II

• Advance AbbVie’s clinical development pipeline by delivering excellence in clinical research
• Partner with investigators and site staff to support effective clinical trial engagement
• Serve as the primary point of contact for investigative sites
• Provide contextual clinical-trial information and connect stakeholders with investigative sites
• Align, train and motivate site staff and principal investigators on trial goals, protocols and patient-treatment principles
• Conduct site evaluation, site training, routine monitoring and site closure activities in compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards
• Customize site-engagement strategies and use CRM tools to track progress and measure impact
• Apply protocol, scientific and clinical-trial expertise to day-to-day trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge to support recruitment and protocol compliance
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues
• Resolve site risk signals and implement preventative and corrective action plans
• Identify and evaluate potential investigators and sites
• Ensure data quality, timely data submission and appropriate safety-event reporting and follow-up
• Maintain audit and regulatory-inspection readiness at assigned sites
• Manage investigator payments according to executed contract obligations, where applicable