I offer robust-diverse clinical expertise taken from career as Bachelor of Science nurse:
I can immediately bring in broad/advanced skill-set developed while educating and coordinating diverse long term health indications, IV-infusion, Phlebotomy, Oncology & HomeIinfusion care needs from within multiple healthcare delivery-clinical research settings. I offer specialized CRA training, trained for common skills critical in the role of flexible primary contact for Sponsor's, practicing as CRA-Monitor. Past CRA-Monitor experience and internships at several research sites has culminated exposure to work needs of the research monitor, to include: site initiation visits, and exposure to various placebo controlled, crossover, adaptive, and medical device studies in their varying phases.
Already a veteran nurse, now Master's-prepared, I remain active in professional organizations like, ACRP-Association Clinical Research Professionals.
Kindly place me in applicable research work, to further synthesize and integrate core principles, further advancing already powerful administrative skill set.
Unexpected Serious Adverse Event learning-capture-dissemination programs.
budgets, Clinical Research, Clinical-Research, CRM, Data Management, financial, Grant writing, Mac, managing, Office, MS-Office, monitors, Oracle, PhD, phlebotomy, processes, process improvement, protocols, recruitment, Research, SPSS, Statistical analysis, STATISTICS, vaccines
Clinical research intern with, Owner-Director of Wichita clinical research site: Professional Research Network (PRN) of Kansas.
•Regulatory binder management
•Filed form 1572s, financial disclosures, CVs, licenses, IB, IP receipts/tracking, e-CRF/source documents and lab manuals
•Data management and archive of regulatory binders after study closeout
•Achieved familiarity with several active randomized, blinded, crossover-adaptive protocols
•Active with investigator-participant coordination, and recruitment-retention plans
•Conceptualized thesis objectives for future PhD work consideration
•Reached out to CROs to communicate interest in bringing new studies onto site
•Discussed operational budgeting, regulatory, ethical and adjudication processes related to managing and identifying serious unexpected adverse events, and adverse event reports captured, learned during research studies
• Explored strong business and financial acumen exercises
• Attention to details, auditing good clinical practices (GCP)
• Continued informed-consent education for consenting trial participants
• Served as research participant's protector and advocate
• Audited subject records for inclusion-exclusion criteria per active study protocol, reconsent with protocol amendments.
• Interacted-collaborated with sponsor's clinical trial monitors
• Reconciled queries using precision during source document verification, Electronic Data Capture, (EDC) Electronic Case Report Forms, and (eCRF) data management
* Skilled with software like: Oracle-Clinical, other Data Mgt.software, and Impala-Interactive-Voice-Response-System, (IVRS/IWRS)
• Managed receipt, shipping, processing and other requirements for study related lab collections, adhering to active trial protocol specifications
• Directed source documents to regulatory binders, meticulously managing captured source data integrity.
• Achieved clinical trial excellence participating in various clinical investigations, involving study for: Chronic Obstructive Pulmonary Disease (COPD), antihypertensive-agents, osteoarthritis treatments and pharmacokinetic, (PK) lab collections and their dry-ice-packing needs.
• Participated with national/international CRO-sponsored clinical trials.
• Attended sponsor teleconference discussing common recruitment issues and remedy
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