and Oncology (Breast Cancer) Monitoring the physician's adherence for Good Clinical Practices (GCP) and the study protocol.
Performing study drug accountability.
Verifying the documentation of the informed consent process for each study subject.
In depth therapeutic and protocol knowledge as provided in company training.
Ensuring that nonserious and serious adverse events are properly documented and reported.
Comparing the case report form to the subject's medical record to ensure completeness and accuracy.
Ensuring the filling and maintenance of the required regulatory documents.
Review all RECIST data point includes, evaluation date, and size of tumor, CT scan or MRI.
Perform Tumor status by calculate whether the Tumor is progressing, stable or partial disease response.
Perform reconciliation of safety and efficacy data, which are as follows, Medical history page, adverse events page, Concomitant medication page, and Dosage Administration record page and RECIST page.
Review new lesion page and reconcile it with overall lesion CRF page to determine overall tumor response.
Performed reconciliation of End of the study CRF page with overall response CRF page to determine reason for discontinuation.
Review Diagnostics and extent of cancer pages and reconcile with prior anti-neoplastic and prior chemo therapy CRF pages for consistency and accuracy.
Ability to perform regionalized travel an average of 70% or more depending on project needs.
Clinical Research Associate, 09/2011 to 03/2013 Patientiq – Chicago, IL,
Clinical Research Associate 1.
Therapeutic area: G.I.
Ulcers), Infectious Disease (HCV) and Cardiovascular (Hypertension and.
Cholesterol Control) Site Selection, Study Start up Activities, IRB submissions and approvals.
Perform routine monitoring of investigative sites, identify and resolved root problems.
Maintain close contact with site personnel and review of regulatory documents required for site initiation.
Review monitoring reports on site issues, and report findings.
Review and approval of ICF; proofreading submitted advertising for recruitment of study subject, and patient retention materials.
Track and report study program progress, performs data review when necessary for accuracy and completeness.
Communicate with Drug Manager regarding drug shipments, storage, accountability, and destruction.
Interact with pharmacovigilance assuring accurate reporting of Adverse Event (AE) Serious Adverse Events (SAEs), protocol deviations, and patient status.
Track CRFs/ eCRFs and communicate any discrepancies/queries with site.
Travel 65 - 80%
Clinical Research Associate, 09/2009 to 09/2011 Patientiq – Chicago, IL,
Therapeutic area: Urology (Phase II, III, IV) Neurology (Phase II, III) and Cardiovascular (Phase II,.
III) Conducted site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
Ensured proper storage, dispensation and accountability of clinical supplies and study drug.
Acted as the principle source of communication between the Study Sponsor, Clinical Investigators and CROs.
Responsible for managing assigned clinical trials, review and sign-off on study specific documentation.
Communicated site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly Verified subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
Ensured Adverse Events are reported appropriately, accurately and in a timely.
Reviewed eCRF, Informed Consent Documents.
Acquired specific clinical and therapeutic knowledge related to studies monitored.
Timely reporting of AEs / SAEs and Protocol Violations, regularly performs Investigational Product (IP) accountability and reviews the status of contents of the site Regulatory Binder.
Maintained a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements.
Travel over 70%
Clinical Research Coordinator, 2007 to 09/2009 Altru Health System Clinic – East Grand Forks, MN,
Ensured smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.
Prepared documentation for submission and review by the (IRB) Institutional Review Board.
Recruit and screen study participants, coordinate their clinical treatment and follow-up care, and help facilitate their continued participation.
Abstracted data from medical records and other sources; collect, submit and maintain study data and regulatory documents; develop and ensure compliance with study protocols; and participate in the planning, development, and budgeting for clinical studies.
Developed collaborative relationships with investigative sites and client company personnels.
Coordinated study start-up regulatory documentation retrieval from investigative sites Disseminated information regarding pertinent study milestones to functional groups associated with study Condensed file review of the investigator and master file Compared the overall quantities of investigational products at the trial site with the amount on the IP receipt/return documents and the individual dispensing records.
Travel over 7%
Education and Training
Bachelor of Science: Psychology, Expected in 1993 to Texas Wesleyan University - Fort Worth, Texas GPA:
Skills
Advertising, Liaison, Conference calls and Data collection.
Binder, budgeting, client, data entry, documentation, filling, Forms, functional,
GCP, IP,
Team Lead, managing, materials,
Microsoft Office Suites, Windows 2000, Oracle, page,
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