Hi, I’m
Natalia Beckenhauer
Director of Clinical Research
Overview
15
years of professional experience
Work History
University Of Nebraska Medical Center
IRB Compliance Analyst
10.2020 - Current
Job overview
- Conduct compliance & auditing operations for routine Post Approval Monitoring (PAM) & For Cause Audit Compliance Measures
- Routine department site visits conducting program research evaluation and appropriate GCP/CITI alignments
- Identify program obstacles and determine appropriate action items/recommendations for problem resolution
- Coordinate and support various Institutional Review Board (IRB) program activities (Standard Operating Procedures, Policy Review, Program Operations, Etc.).
Barrett Clinic, PC
Clinical Research Nurse / Trial Pharmacist
05.2017 - Current
Job overview
- Unblinded coordinator/pharmacist, Research Nurse for Primary and Preventative Care Conditions
- Maintain regulatory compliance and management; sustain records of study activities, drug dispensation records & regulatory forms
- IP lead and direct requisition, collection, labeling, storage, and shipment of specimens with routine audit and verification methods (DOT/IATA certified).
- Communicates current trial status and sponsor expectations; proactive in addressing changing priorities
University Of Nebraska Medical Center
Research Nurse Manager - Cardiothoracic/Ortho Surg
04.2015 - 10.2020
Job overview
- Direct, manage, monitor, guide, and control all aspects of current and prospective clinical trial research projects (CCRC certified).
- Effectively lead & motivate cross-functional teams (OR staff, Perfusion, ICU, LVAD team, CathLab, CPCU, Echo, Radiology, Residents, PT, Infectious Disease).
- Process samples and align shipping & receiving policies to adhere to the research protocol and state, federal, and institutional policy requirements (CLIA verification, IATA/DOT certified).
- Operational management of Investigator & Sponsored initiated trials (e.g., budgeting, regulatory maintenance, evaluating, and conducting necessary training within all departments across the institution.
- Management & accountability for trial administrative and financial aspects (e.g., project selection, planning, initiation, invoicing/budgeting, staff education, and patient screening/enrollment).
- Conduct oversight in billing/invoicing/auditing (time, quality, cost) across programs and evaluate cost savings analysis for each trial.
- Project Management of complex protocols, device trials, IND initiation, HUD, Phase I-IV medication trials, Emergency & Compassionate use applications.
- Possess strong commitment to team environment dynamics with the ability to contribute expertise and follow leadership directives at appropriate times.
- Delegate and effectively prioritize duties throughout changing environments based on relevant skill sets.
- Drive team of providers to develop effective recruitment strategies to ensure consistent working to identify and recruit patients to meet enrollment goals & proactively identify and analyze project risks.
- Sponsor contact and site liaison for CRO review, site feasibility, budget negotiation, SIV, training, regulator, IP accountability, amendments, and close-out procedures.
- Conduct Interview sessions and yearly staff appraisals, orient and train new personnel to the department.
- Research educator for providers & staff within various departments for trial implementation instilling collaborative practices to meet program goals.
- Monitor, Assess, and Identify Adverse Events stemming from any possible association with using a study drug or investigational device.
- Engage IT interfacing functionalities to support clinical research throughout patient care admissions (pre-admission, immediate/urgent, operative measures and post-operative admission, follow-up cares/activities & facilitation throughout trial participation).
- Constructing contracts for purchasing, provide device reconciliation, establish PAR supply levels, OR research procedures.
- Ensure escalation pathways are followed, and communication is relayed to PI, Sub-I's, Regulatory bodies & Medical Monitor.
- Obtain required documents & clearances, certificates, and approvals from institutional, state, and federal agencies.
Dermatology Specialists Of Omaha
Aesthetic & Lead Staff Nurse
03.2014 - 04.2015
Job overview
- Managed & led team comprised of RNs, LPNs, and ancillary staff through orientation, role development, and goal expectations.
- Perform administrative/ managerial functions (e.g., unit's staffing, planning & long-range goals).
- Consult and coordinate with healthcare team members to assess, implement, and evaluate patient care plans through triage.
- Assist in various clinical procedures, including biopsies, laser therapies, cryotherapy, excisions, ED&C, electrocautery, focused physical examinations, patch testing, botox placement and dermal fillers.
Nebraska Spine Center
Nurse Care Coordinator
09.2010 - 03.2014
Job overview
- Nursing lead responsible for monitoring departmental goals, orienting new hires, float coordinator/patient escort/liaison for workers' compensation.
- Conduct preoperative/postoperative assessments, detailed patient education instruction, and follow-up for continuity of care in recovery.
- Direct management of surgery/outpatient scheduling, telephone triage, obtaining/entering patient health histories, and preparing patients for various outpatient clinic procedures.
Skin Specialists Of Omaha
Dermatology & Aesthetic Research Nurse
11.2008 - 09.2010
Job overview
- Dermatologic and Aesthetic Research Nurse responsible for the launch, screening, and enrolling of sponsored research trials.
- Provide education and patient care guidance to the particular needs of each skincare condition.
- Product knowledge of skincare lines while guiding recommendations for the prevention of skin concerns.
- Clinical research pharmacist responsible for inventory, recording, monitoring, ordering, and dispensing.
- Unblinded pharmacist responsible for maintaining blind of investigation product by preparing and compounding medication assigned to appropriate randomized arm.
- Conduct clinical duties: extensive health histories, collection of laboratory blood work, performing EKGs, thorough patient education, preparing patients for physical exams & procedures, and telephone triage.
- Assist with patient care procedures, including examinations, biopsies of melanomas, and broad scope of possible pre-cancerous conditions, treatment of acne, rashes, psoriasis, rosacea, actinic keratosis, eczema, onychomycosis, hidradenitis suppurativa.
- Address patient inquiries, such as test results, prescription refills & patient education.
- Practiced and maintained study records, including case report forms, drug dispensation records, regulatory documents, and IP invoices.
- Assess the eligibility of potential subjects through screening interviews, medical records, and physician partners.
Education
University Of Nebraska Medical CenterOmaha
Doctor of Nursing Practice from Nursing
05.2023
University of Nebraska Medical CenterOmaha
Bachelor of Science from Nursing
12.2018
College of Saint MaryOmaha, NE
Associate of Science from Nursing
05.2008
Skills
- Adept Clinical Trial Project Management
- Prioritizing & Managing Deadlines
- Team leadership & Department Liaison
- Policy Formation & Regulation Management
- Research Applications (Advarra, WCG, NCI, CTEP, CTMS, Merge, Oracle, Tempo, Medidata, IRT, IVRS, EDC, CTMS, regulatory applications)
- Computer competencies (Research & Academic Applications, Microsoft Office, Adobe, EMRs, RedCap )
- Budgeting & Finance Trial Matrices
- Proven critical & analytic strategic skillset
- Commercial/Sponsored, Academic, Private Practice Research Practice Proficiencies
- Effective oral & written communication & presentation skills (published)
Accomplishments
- Proficiency in device trials, IND/IDE phase & feasibility trials, Phase I-IV drug trials
- Launched & managed six large national trials and over 12 physician-initiated trials
- A proven expert in research practices evidenced by two successful audits (FDA, Internal IRB)
- Experienced in Compassionate Use, Emergency Use, Registry, HUD application, and practices
- Increased department medical research trial volume growth by 500% over four years & repeated top 10 enroller
- Established foundation to support nationally recognized trials through sponsor transparency and project delivery aims
- Expertise in Primary Care, Vaccines, Dermatology, Cardiovascular, Respiratory, Cardiothoracic Surgery, and Orthopedic Clinical Trials & Device Integration
Publications
First author of article Nursing Quality & Care; Co-author of 4 Scientific Articles
Timeline
IRB Compliance Analyst
University Of Nebraska Medical Center
10.2020 - Current
Clinical Research Nurse / Trial Pharmacist
Barrett Clinic, PC
05.2017 - Current
Research Nurse Manager - Cardiothoracic/Ortho Surg
University Of Nebraska Medical Center
04.2015 - 10.2020
Aesthetic & Lead Staff Nurse
Dermatology Specialists Of Omaha
03.2014 - 04.2015
Nurse Care Coordinator
Nebraska Spine Center
09.2010 - 03.2014
Dermatology & Aesthetic Research Nurse
Skin Specialists Of Omaha
11.2008 - 09.2010
University Of Nebraska Medical Center
Doctor of Nursing Practice from Nursing
University of Nebraska Medical Center
Bachelor of Science from Nursing
College of Saint Mary
Associate of Science from Nursing
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