Emily Mcdade Email & Phone Number

Dallas, TX, US

Dallas, Texas, United States

• Tracking site compliance and source documentation verification ensuring accuracy and GCP compliance
• Assisting other travel CRAs with filing, site communications, filing and documentation.
• Attending Sponsor calls with active feedback on project timelines status.
• Preparing, handling distributing, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• On-site document retrieval in accordance with GCP and Sponsor regulations.
• Verification of protocol deviations, serious adverse events, concomitant medication to confirm accurate data reporting in accordance with the protocol.

Dallas, Texas, United States

• Updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Preparing, handling distributing, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Financial liaison between Investigators/site to CRO/Sponsor; developing payment processes per contract and budget
• Tracking and managing clinical trial supplies; Case Report Forms (CRFs); queries; and clinical data flow.
• Preparing for all investigator meetings and study initiation visits.
• Purchasing of study‐specific equipment/supplies and budget activities.

Dallas, Texas, United States

• Skilled in project management of clinical trials; supporting trial development, outreach, and study start up for site activation to enroll patients in scientific and procedural requirements
• Review study protocols, reimbursement guidelines, vendor responsibilities/requirements, lab, and assist in activating drug supply through IVRS, and patient recruitment projections.
• Problem solve with CRO/Sponsor and on recruitment hurdles, new clarifications, or slot allocation/cohort openings weekly or biweekly.
• Operationally with different clinic teams prepare to activate the site after start up visit ensuring all necessary kits, drug, and computer access is set up appropriately – and working with CRO Trial Managers to meet.

Dallas, Texas

• Under direct supervision, enlist, maintain and assure accurate medical history for all patients in the clinic.
• Coordinate new patient referral paperwork and conduct initial consult meeting.
• Complete clinical workup to include patient's treatment course, medical history, current condition/medications.
• Identify appropriate trials looking at eligibility criteria (i.e. inclusion, exclusion, prohibited medications) along with communicating with sponsor/pharmaceutical company regarding trial slot allocation and enrollment.
• Collaborate with provider to determine appropriate plan of care and ensuring a clear line of communication with patient's referring physician and patient.
• Ordering and preparing any provider requested molecular diagnostics and/or study specific tissue testing (i.e. Tempus, Foundation One, Guardant 360).

Dallas, Texas

Promoted to Data Coordinator II

Dallas, Texas

• Under supervision, gather correct and current data on subjects enrolled in clinical trials. Follow process ensuring the data is appropriately collected, filed, entered, cleaned, and maintained from initial enrollment.
• Maintain all research protocol data and compliance reporting for pharmaceutical company (Sponsor).
• Proficiency in Microsoft Office including MS Word, Excel, and PowerPoint; MS Outlook and Internet Explorer.

Bachelor'S Degree, Kinesiology - Physical Activity & Health

Activities and Societies: Kappa Kappa Gamma, Philanthropy Chairman, Reading Is Fundamental (RIF), Run to Read, Book Fair for Project.

Minor, Rural Sociology And Community Development