Cassie Coffman

• Accountable for global CSM study-level deliverables, serves as a primary CSM functional lead, and directs assigned ASML(s) daily activities
• Develops and executes operational study-level strategies to be implemented by CSM Country teams.
• Planning and execution of clinical programs, vendor selection processes, CSM study execution, and risk mitigation on study-level.
• Accountable for driving site management activities from study start-up through study closeout ensuring delivery of site selection/activation, subject recruitment, protocol compliance, data quality and adherence to monitoring plan.
• Ensures inspection readiness throughout the lifecycle of studies.

• Responsible and accountable for directing CRAs in a matrix environment and for driving the successful execution of Clinical Site Management (CSM) study deliverables for assigned studies within geographical Area.
• Provide monitoring expertise and ensure on-time and quality CSM deliverables (data, monitoring plan, SOPs, regulations).
• Function as a liaison and primary contact between CRAs and Global Site Management Lead (GSML).
• Manage and oversee day-to-day monitoring activities on assigned studies to ensure CSM deliverables are met by tracking and maintaining project metrics and status of deliverables.
• Proactively communicate and escalate issues, risks and mitigation plans to Area/Country Leadership and GSML.

• For assigned sites/studies ensure successful protocol level execution of monitoring deliverables involving start-up, conduct, close-out and inspection readiness.
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

• For assigned sites/studies ensure successful protocol level execution of monitoring deliverables involving start-up, conduct, close-out and inspection readiness.
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

• For assigned sites/studies ensure successful protocol level execution of monitoring deliverables involving start-up, conduct, close-out and inspection readiness.
• Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.

• Research coordinator for multiple clinical trials and registry research studies for hepatology

• Consent, screen and enroll patients and conduct subject visits

• Complete regulatory documents, study start up activities and IRB submissions

• Data management, quality assurance and quality control

• Lab processing, drug reconciliation and shipments

• Identify and write all AE and SAE reports

• Budget and Financial Management of clinical studies

• Conduct ongoing study continuation activities

• Implement strategies for recruitment and retention of subjects.

• Assist in protocol development and authoring of manual of procedures