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.• Central in‐house contact for the clinical team for designated project communications, correspondence and associated documentation.• Developing and implementing new and innovative ideas and processes for site relationships and Sponsor needs.

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 activation needs.

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).• Quality check the provider consult note to the medical history document and make changes as needed so they are consistent.• Knowledge of our open trials, their mechanism of action, and protocol requirements.

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 through follow-up care. • 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