Roxanne Mcintosh Email & Phone Number

• Manage and monitor all laboratory aspects of assigned clinical trials and act as the main point of contact for the customer from study start up to closeout.
• Facilitate study initiation by working with Setup team including leading meetings; creating project plans and milestones; assessing and mitigating project risks; identifying and resolving issues; and creating and.
• Monitor clinical projects, timelines, and deliverables; manage and file study documentation; review study maintenance and reporting; and conduct regular study meetings to ensure study and customer needs are realized.
• Maintain study budget monitoring and lead modifications as needed.
• Serve as an escalation point for study level issues, implement changes, and establish project improvement as required.
• Build and maintain customer relationships, and establish clear communication with sites, clinical research associates n(CRAs), and customers to manage on-going project expectations and issues. Collaborate across.

Katy, Texas, United States

• Responsible for the overall coordination, organization and implementation of research studies, over multiple medical disciplines including but not limited to gastroenterology, gynecology, and rheumatology. Obtain open.
• Screen and enroll study participants ensuring consistency in data quality and integrity, including scheduling subject visits and coordinating physicians/other staff availability.
• Complete and document study visit procedures including: obtaining informed consent; explanation of study procedures; conducting patient interviews; biological sample collection, preparation and shipment; ECG tracing or.
• Providing accurate and timely feedback to physicians, pharmaceutical companies and study participants; regulatory submission for existing studies in conjunction with sponsor and IRB requirements; attending project.
• Creating and updating study documents, managing study related essential/regulatory documents, ensuring proper inventory level of study supplies, and maintaining protocol compliance and timeline adherence along with.
• Maintaining compliance with study protocol, SOPs, and state and federal regulations while utilizing certifications to comply with all GCP, HIPAA, and IATA requirements.

Austin, Texas Area

• Recruited, vetted and processed hundreds of subject volunteers to participate in Phase I research studies via telecommunication followed by in person interviews and physical testing to ensure subjects were physically.
• Led subjects through Informed Consent Sessions as delegated by the principal investigator.
• Initiated research studies using a variety of computer software systems and collaborating across multiple company departments, prepared and translated source documents, lab requisitions, clinical labels, physical.
• Recorded vital signs, performed electrocardiograms (ECGs), executed phlebotomy procedures, assisted principal investigators in exams, performed pulmonary function assessments, recorded and updated adverse events.

Austin, Texas Area

• Ensured timely harvest of laboratory specimens and accurate recording of data.
• Executed technical procedures including phlebotomy, finger sticks, glucometer testing, bleeding time testing, vital signs, pulse oximeter readings, ECGs, Holter hook-ups and checks, clinical urine collection and urine.
• Performed other non-technical procedures as assigned, including assisting with physical examinations.

Master'S Degree, Biology

Bachelor'S Degree, Marine Biology