Erin Delaney
Indianapolis,IN
Summary
Versatile clinical research professional prepared for impactful contributions. Five-years of clinical research experience in neurosurgery and genetic biospecimens. Strong background in clinical trial coordination, regulatory compliance, and patient management. Educated in neuroscience, anatomy and physiology, biology, statistics, and medical terminology. Skilled in data management, protocol creation, and maintaining high ethical standards. Effective collaborator, adaptable to changing needs, and consistently reliable in team settings.
Overview
12
12
years of professional experience
1
1
Certification
Work History
CERTIFIED CLINICAL RESEARCH COORDINATOR
Department of Medical and Molecular Genetics at Indiana University School of Medicine
08.2022 - Current
- Onboard multiple research studies in pursuit of investigating neurodegenerative disease through genetic testing of biospecimens
- Train external study teams on company protocols related to biospecimen collection, processing, and shipment
- Create custom technical documents such as manual of procedures, case report forms, training slides, and data dictionary
- Maintain strict version control of internal and external technical documents
- Present company overview and study services at Investigator Conference
- Develop, maintain, and reconcile databases
- Oversight of team members to ensure quality and efficiency
- Design REDCap projects for multiple purposes
- Communicate regularly with external sponsors and stakeholders to implement efficient processes and effective problem resolution
- Establish Material Transfer Agreements and related Appendices
CERTIFIED CLINICAL RESEARCH COORDINATOR
Goodman Campbell Brain and Spine
03.2021 - 08.2022
- Coordinated successful clinical trials by maintaining regular communication with study sponsors, investigators, and research staff
- Completed regular monitoring visits with high marks for regulatory compliance
- Experienced in electronic data capturing systems and query resolution
- Experienced in proper maintenance of research source documents, screening logs, and delegation of authority logs
- Maintained compliance with clinical trial operations in accordance with GCP and ICH guidelines
- Assessed potential serious adverse events and adverse events in collaboration with Principal Investigator and Sub-Investigator
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity
- Reported serious adverse events and adverse events in accordance to FDA regulations and sponsor requirements
- Participated in study start-up and study close out
- Attended surgery and patient procedures for the collection of research study data and assurance of study compliance
- Maintained product accountability used in IDE study by meticulous tracking and recording processes
- Conducted patient study visits including interviews, physical assessments, and questionnaires
- Completion of Informed Consent Processes and documentation following GCP and ICH guidelines
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Completion of local and national submission to IRB including continuing reviews, reportable new information, and protocol changes
- Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities
RESEARCH DATA COORDINATOR
Goodman Campbell Brain and Spine
11.2019 - 03.2021
- Created research databases using coding and informatics in accordance with protocol and study goals
- Managed databases for multiple projects
- Abstracted high quality data for retrospective stroke database for thousands of patients
- Collaborated with Principal Investigators to develop data points, database organization, and calculations
- Interdepartmental correspondence in execution of project timelines and study goals
- Lead study coordinator for national and local registries
- Maintained correspondence with Sponsors, PI, and IRB
- Resolution of issued queries through EDC systems
- Creation and maintenance of source worksheets, subject and regulatory binders in accordance with protocol, local and federal regulation
MEDICAL OFFICE ASSISTANT
Goodman Campbell Brain and Spine
02.2019 - 10.2019
- Adhered to strict HIPAA guidelines to protect patient privacy
- Collected vital signs, medical history, and diagnostic review of patients
- Administered patient questionnaires to evaluate past and current medical concerns
- Maintained medical examination rooms with proper supplies for physicians
- Streamlined processes within clinic to maximize efficiency in physician schedule distribution and patient satisfaction
LEARNING RESOURCE CENTER ASSISTANT
Ivy Tech Community College
01.2018 - 05.2018
- Showed patrons where to find library resources, equipment, and references
- Front desk check in for students requiring tutoring services
- Fielded questions regarding services, availability, and contact information
- Maintained resource center supplies through inventory and order placement
FRONT DESK REPRESENTATIVE
Indianapolis Gastroenterology and Hepatology
08.2012 - 10.2015
- Greeted visitors and customers upon arrival, offered assistance
- Verified accurate medical insurance, demographic information, and completion of office documents
- Scanned and charted physician dictations for 17 different providers
- Ordered and distributed all supplies for various departments
Education
Bachelor of Science - Medical Humanities and Health Sciences
IUPUI
Indianapolis, IN01.2024
Associates of Science -
Ivy Tech Community College of Indiana
Indianapolis, IN01.2018
Skills
- Manual of Procedures
- Training Materials
- Biospecimen Training
- Medical Device Trials
- Regulatory Compliance
- Electronic data capture systems
- IRB submissions
- Informed Consent Process
- Adverse event reporting
- Source document verification
- Interdepartmental collaboration
- REDCap project development
Certification
Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates, 2021
Accomplishments
- Published on Ruth Lily Medical Library Website, 2024
- Passport to IUPUI Scholarship, 2018
Timeline
CERTIFIED CLINICAL RESEARCH COORDINATOR
Department of Medical and Molecular Genetics at Indiana University School of Medicine
08.2022 - Current
CERTIFIED CLINICAL RESEARCH COORDINATOR
Goodman Campbell Brain and Spine
03.2021 - 08.2022
RESEARCH DATA COORDINATOR
Goodman Campbell Brain and Spine
11.2019 - 03.2021
MEDICAL OFFICE ASSISTANT
Goodman Campbell Brain and Spine
02.2019 - 10.2019
LEARNING RESOURCE CENTER ASSISTANT
Ivy Tech Community College
01.2018 - 05.2018
FRONT DESK REPRESENTATIVE
Indianapolis Gastroenterology and Hepatology
08.2012 - 10.2015
Associates of Science -
Ivy Tech Community College of Indiana
Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates, 2021
Bachelor of Science - Medical Humanities and Health Sciences
IUPUI
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