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 reviewing study documentation during study start-up phase. •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 throughout the trial duration. •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 operational areas to manage study scope changes and ensure efficient study operations. •Provide study training to CRAs and customers. Mentor and train less experienced team members. •Conduct projects in compliance with internal standard operating procedures, policies, and good clinical practices.

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, clear, and effective communication with the physicians, patients, study sponsors, Institutional Review Board, and internal management.•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 other diagnostic information collection; distributing investigational product and other supplies; scheduling follow-up visits etc.•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 specific training and conduct cross training for other research staff members; and coordinating sponsor monitoring visits and audits.•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 following regulation and protocol established for each study.•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 qualified to participate in the Phase I research study.•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 forms, and any other required documentation to accurately capture all data outlined by study protocols in regard to subject inclusion and exclusion criteria.•Recorded vital signs, performed electrocardiograms (ECGs), executed phlebotomy procedures, assisted principal investigators in exams, performed pulmonary function assessments, recorded and updated adverse events, administered investigational drugs using various oral dosing methods including capsules, tablets, liquids, and oral syringes, and performed any other specialized procedures as needed by team administrators.

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 drug screening. •Performed other non-technical procedures as assigned, including assisting with physical examinations.

Master'S Degree, Biology

Bachelor'S Degree, Marine Biology