Pearland, Texas, United States
I have 18 years experience in the Clinical Research industry in Phase I, II and III trials. Currently, I am working as a Clinical Data Reviewer on Phase II-III Oncology-Multiple Myeloma studies. The majority of my previous experience has been in Clinical Site Management and as a Clinical Research Associate. My therapeutic experience includes 15 yrs in Oncology of various indications, Infectious disease, Pain/Analgesics, Multiple Sclerosis, & Ophthalmology. I also successfully reviewed as one of the few clinical data reviewers on the light speed Covid-19 vaccine clinical trial where over 43,000 subjects were rapidly enrolled over 4 months.
Data Review Team - Dedicated to Pfizer Clinical Studies - Oncology * Supports various studies, most often in a submission timeline, by assisting study teams with their data review. The studies are often phase 3 pivotal trials that are high-enrolling and require robust data capture. * Works in conjunction with each study team to support existing data review requirements. * Review tasks include both point-to-point checks, e.g. verifying the presence of a blood pressure value that satisfies study inclusion criteria, and interpretive analysis, e.g. evaluating subjects to find inconsistencies in the patient profile of data. * The interpretive review portion of the responsibilities requires being knowledgeable about the therapeutic area under investigation, expected, affects of the investigational drug and supportive medications, and possess enough medical knowledge to assess if patient data is logical.
* Conducts remote data review within various systems (EDC, IVRS, etc.) to ensure protocol compliance * Identifies adverse events, protocol deviations, and other unanticipated potential patient safety issues, and escalates appropriately * Communicates and liaises effectively between Clinical Research Associates, Project Team members, and site staff * Maintains project tracking systems as required * Interprets data to identify protocol deviations or major risks to data integrity and generates queries where applicable * Attends Project Team teleconferences and may provide status and trending analysis updates * Maintains a working knowledge of GCP/ICH Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes * Completes assigned training programs and applies learning to daily work
* Obtain, review for appropriateness, and process regulatory and administrative documents from investigative sites * Recruit investigators for participation in clinical trials * Negotiate study budgets with investigators * Develop site management plan in conjunction with field-based staff * Review draft protocols for completeness and feasibility * Develop care report forms (CRF) for clinical trials * Present (e.g. study specific guidlines and procedures, case report forms, and monitoring conventions) at Investigator Meetings * Prepare and process Serious Adverse Event (SAE) reports * Prepare project management reports * Review and verify CRFs and other clinical data for completeness and accuracy; generate queries * Resolve queries with study site personnel * Review Tables and Listings generated from study data * Monitor (pre-study, initiation, routine, and close-out) onsite and remote visits at investigator sites for GCP compliance according to PharmaNet/i3's SOPs and/or client guidelines * Assist in writing Clinical Study Reports * Train junior Clinical Project Associates on monitoring, internal procedures, and query resolution
* Worked independently as clinical research coordinator of complex clinical research protocols, phase II-IV responsible for organizing the documentation and files pertaining to studies * Coordinated the activities of clinical investigators and subjects * Followed Office of Clinical Research (OCR) and Baylor College of Medicine standard operating procedures; abided by federal regulations, and ICH-GCP guidelines. * Conducted testing procedures required by study protocol (medical history interview, vital signs, specimen collection & processing, collect and enter data into case report forms, reporting to study monitors). * Answered and responded to patient / subject calls, maintain database of patient / subject demographics * Coordinated subject recruitment activities with study team * Acted as liaison between Baylor College of Medicine and affiliated institutions * Coordinated and scheduled research subject appointments for tests and procedures * Maintained records for clinical study and regulatory documents in confidential and HIPAA compliant manner * Assisted in determining patient eligibility for research protocols * Ordered supplies and equipment necessary to support recruitment efforts
Oversaw all phases and areas of clinical trials including budgeting, Good Clinical Practices (GCP), Institutional Review Board (IRB) protocol submissions, and on-going regulatory and IRB phases; acted as liaison with physicians and drug companies for contract negotiations. Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection forms. Exhibited project management abilities with capacity to design, plan, and implement ideas from conception through completion; able to manage multiple responsibilities without compromise to detail or quality; facilitated completion of clinical charts and case report forms. Controlled quality of data retrieved from hospital records. Documented adverse event reports and obtained MD signatures; submitted these to sponsor and IRB; corresponded with IRB coordinators to coordinate smooth operations of these approvals. Medical office operations: responsibilities included administrative and billing issues. Managed the eye clinic, handled paperwork associated with surgeries; prepared patients for surgery (LASEK, cataract, corneal transplants). Performed technical duties, ie. refractions, visual acuity, slit lamp exams, pneumometer pressure, ocular surface exams, serum preparation, confocal microscopy.