Natasha Nerczuk
Summary
Versatile clinical research professional knowledgeable about coordinating complex, sponsor-initiated clinical trials in cardiovascular medicine, phases I through III. Offering skills in regulatory processes, professional communication, leadership, teamwork, attention to detail and pride in my work. Experienced in facilitating clinical operations relating to cardiovascular interventional clinical trials at a high enrolling/performing site. Accomplished in interpreting complex protocols, data auditing and monitoring, navigating regulatory systems and bringing study design to fruition from study start-up to closeout.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate
Knight Cardiovascular Institute
06.2020 - Current
- Work with principal investigator and sponsors to facilitate daily cardiovascular trial activities and comply with research protocols phases I-III.
- Collect data and follow research protocols, operations manuals and case report form requirements.
- Maintain compliance with protocols covering patient care and clinical trial operations.
- Oversee study start-up activities such as IRB development, sponsor negotiations, site visits and collaborating with ancillary departments.
- Conduct site monitor visits and audits.
- Manage regulatory requirements and documentation.
- Onboard/train new study staff on KCVI and sponsor protocols.
- Screen patient records, databases and physician referrals to identify prospective candidates for research studies.
- Maintain energy and enthusiasm in fast-paced environment.
- Proven successful performing within tight deadlines and fast-paced atmosphere.
- Use critical thinking to break down problems, evaluate solutions and make decisions.
- Establish and maintained courteous and effective working relationships.
Patient Access Specialist
Oregon Health & Sciences University
11.2018 - 06.2020
- Oversaw daily activities of busy outpatient Non-Invasive Cardiovascular Procedure Lab (echocardiograms, exercise stress tests, ECG's/heart monitors).
- Facilitated communication and streamlined workflows to ensure multiple teams within the department ran smoothly.
- Implemented service improvements to minimize recurring patient issues and complaints.
- Collaborated with hospital departments to coordinate complex patient care.
- All new employee training.
Education
Bachelor of Arts - Health Administration
George Fox University
12.2015
Skills
- IRB maintenance: study development/ modification/RNI/ study close-out
- Site Qualification/Initiation/Monitoring Visits
- Source documentation creation/auditing
- Sponsor audits
- Regulatory documentation
- Adverse event reporting
- eRegulatory systems
- Vendor collaboration
- Collaboration/communication
Accomplishments
- Presented with 'Top Coordinator 2022' award from Heart Failure Society of America by external nomination
- Presented as content expert at SEQUOIA-HCM 2022 Investigator Meetings in San Diego, CA and Amsterdam
- ICH/GCP/RCR/HSR/Biosafety Certified (CITI)
Timeline
Clinical Research Associate
Knight Cardiovascular Institute
06.2020 - Current
Patient Access Specialist
Oregon Health & Sciences University
11.2018 - 06.2020
Bachelor of Arts - Health Administration
George Fox University
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