MARYANN HOLLEN
Summary
Dynamic and detail-oriented Clinical Research Professional with extensive experience in managing clinical trials across diverse medical fields, including CNS, Oncology, and Neurosciences. Proven track record in ensuring compliance with regulatory standards, enhancing patient safety, and fostering collaboration among cross-functional teams. Committed to advancing medical research and improving patient outcomes through ethical practices and innovative problem-solving
Overview
5
5
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator
Carilion Medical Center
06.2021 - Current
- Manage teams of Clinical Research Coordinators and Clinical Research Assistants across specialties of Interventional Radiology, Nuclear Medicine, CNS, Oncology, and Pulmonology
- Work closely with Clinical Research Associates (CRAs) to conduct and oversee site initiation visits (SIV), Interim monitoring visits (IMV), and Site Close Out Visits
- Partner with trial sponsors to develop clinical trial protocols
- Collaborated with cross-functional teams to boost patient recruitment, resulting in a 35% increase in enrollment rates.
- Conducted training sessions and workshops for clinical staff on Good Clinical Practice (GCP) guidelines and data management procedures, achieving improved compliance rates.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Independent Contractor
Carilion Medical Center
07.2020 - 06.2021
- Primary data specialist on research collaboration between Psychiatric and Emergency Departments entitled, “Emergency Department Bridge to Treatment Program: Bridging patients with opioid use disorder to rapid access of buprenorphine and office-based opioid treatment”
- Reviewed patient medical records to determine study inclusion/exclusion
- Abstracted qualitative and quantitative research data from electronic patient medical records (EPIC) and enter into REDCap
- Perform quality audits of research data
- Interpreted and code drug screening results
- Analyze medication prescriptions written by physicians for data entry
- Worked with PI to analyze data and write reports on study results
- Collaborate to develop presentations for program dissemination across other emergency departments across Virginia
- Research data trends to uncover patterns impacting the future course of clinical care
Applied Behavior Analysis Clinician’s Assistant (Internship)
Family Preservation Services
08.2020 - 12.2020
- Provided in-home clinical interventions for youth with behavioral challenges
- Documented and tracked youth behaviors throughout course of treatment
- Participated in case review sessions with Clinical Coordinator
Crisis Advocate
Concern Hotline
08.2020 - 12.2020
- Provided confidential crisis intervention, emotional support, and informational services to callers
- Dispatched emergency psychiatric services when necessary
- Assured adherence to organizational policies and procedures
Education
B.S. - Psychology, Public Health
Shenandoah University
Winchester, VA05.2021
Skills
- Certified Clinical Research Professional (CCRP)
- ICH, FDA, GCP
- CITI Certifications in Essentials of Grant Proposal Development, Essentials of Research Administration, Conflicts of Interest, and Biomedical Researchers
- Risk-Based Monitoring
- Proficient in medical and scientific terminology
- SPSS statistical software
- Trained in mental health crisis intervention
- Leadership skills: Supervisory and staff coordination experience
- Conversational German
Certification
- CITI: Biomedical Responsible Conduct of Research, Conflicts of Interest, Essentials of Grant Proposal Development, Essentials of Research Administration, Good Clinical Practice
- IATA-Mayo Clinic: Certificate of Training for Handling/Transportation of Dangerous Goods (Category A: Infectious Substance Affecting Humans, Category B: Biological Substances)
Awards
Carilion SHINE Award Winner (Quality Award)-2022, Shenandoah University Player of the Year nominee-2018, Shenandoah University Rookie of the Year nominee-2018, Shenandoah University Student-Athlete Record-Breaking Performance nominee-2018
Affiliations
- Association of Clinical Research Professionals (ACRP)
- Carilion Clinic Community Engaged Research Committee
Timeline
Lead Clinical Research Coordinator
Carilion Medical Center
06.2021 - Current
Applied Behavior Analysis Clinician’s Assistant (Internship)
Family Preservation Services
08.2020 - 12.2020
Crisis Advocate
Concern Hotline
08.2020 - 12.2020
Independent Contractor
Carilion Medical Center
07.2020 - 06.2021
- CITI: Biomedical Responsible Conduct of Research, Conflicts of Interest, Essentials of Grant Proposal Development, Essentials of Research Administration, Good Clinical Practice
- IATA-Mayo Clinic: Certificate of Training for Handling/Transportation of Dangerous Goods (Category A: Infectious Substance Affecting Humans, Category B: Biological Substances)
B.S. - Psychology, Public Health
Shenandoah University
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