Emily Nelson
Novato,United States
Summary
Knowledgeable clinical research specialist with over ten years of experience in managing and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and ICH-GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed with strong organizational skills and adaptability.
Overview
10
10
years of professional experience
Work History
Senior Clinical Research Associate
IQVIA
09.2021 - Current
- Perform site selection, initiation, monitoring and close-out visits as applicable in accordance with contracted scope of work and good clinical practice
- Accountable for supporting development of project subject recruitment plan on a per site basis
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalate quality issues as appropriate
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Support start-up phase as applicable
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Build awareness of features and opportunities of study to site
- Collaborate and liaise with study team members for project execution support as appropriate
- Provide mentorship to incoming CRA's.
Clinical Research Associate
PPD
02.2021 - 08.2021
- Performed site selection, initiation, monitoring and close-out visits as applicable in accordance with contracted scope of work and good clinical practice
- Accountable for supporting development of project subject recruitment plan on a per site basis
- Worked with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalated quality issues as appropriate
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Supported start-up phase as applicable
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Built awareness of features and opportunities of study to site
- Collaborated and liaised with study team members for project execution support as appropriate.
Clinical Research Associate
IQVIA
01.2020 - 02.2021
- Performed site selection, initiation, monitoring and close-out visits as applicable in accordance with contracted scope of work and good clinical practice
- Accountable for supporting development of project subject recruitment plan on a per site basis
- Worked with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalated quality issues as appropriate
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Supported start-up phase as applicable
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Built awareness of features and opportunities of study to site
- Collaborated and liaised with study team members for project execution support as appropriate.
Clinical Research Coordinator
Sutter Health
03.2019 - 02.2020
- Administrative management
- Study start-up including recruitment
- Patient management including retention
- Close-out activities
- Liaison for sponsors and clinical research organizations
- AE/SAE reporting and IRB submissions
- Followed regulatory standards in compliance with the IRB, FDA, and GCP
- Developed, organized, and managed clinical trial databases/documents
- Managed outside vendors
- Staff and physician training
- Lab processing and handling of biological samples carried out in per IATA.
Clinical Research Coordinator
The Public Health Institute
12.2017 - 03.2019
- Administrative management
- Study start-up including recruitment
- Patient management including retention
- Close-out activities
- Liaison for sponsors and clinical research organizations
- AE/SAE reporting and IRB submissions
- Followed regulatory standards in compliance with the IRB, FDA, and GCP
- Developed, organized, and managed clinical trial databases/documents
- Managed outside vendors
- Conducted Clinical interviews.
Behavioral Therapist
Milestones
04.2016 - 12.2017
- Conducted individual and group therapy for children with mental health needs through means of Applied Behavior Analysis
- Quantitative and qualitative patient data analysis and case management.
Administrative Research Assistant
The University of California San Francisco
11.2013 - 06.2016
- Administrative management
- Initiated projects for study design
- Patient recruitment and patient management
- Conducted neuropsychological testing with patients along with clinical interviewing
- Tracking and upkeep of regulatory documents.
Education
Bachelor of Science - Cognitive Science
University of California Berkeley
01.2012
Bachelor of Arts - Psychology
University of California, Santa Cruz
01.2012
Skills
- Site management
- Clinical research monitoring experience
- ICF/Study document development
- Protocol development
- Patient recruitment
- Expert Knowledge of EDC, IRT, eCOA Systems
- eTMF experience
- Patient safety monitoring
- Vendor liaison
- Regulatory submissions
- Accountability/Supply reconciliation
- Action planning
- Data evaluation
- Quality management
- Mentorship/Training
- Interdepartmental collaboration
Languages
English
Publications
- Randomized Clinical Trial of Intensive Motivational Interviewing for Women with Alcohol Use Disorders: 6-Month Outcomes, Douglas L. Polcin, Madhabika B. Nayak, Rachael Korcha, Sheila Pugh, Jane Witbrodt, Michelle Salinardi, Gantt Galloway, Emily Nelson, J Psychoactive Drugs, 2019 Nov-Dec, 51, 5, 421-430, PMC6823106, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6823106/
- Being with a Buddha": A Case Report of Methoxetamine Use in a United States Veteran with PTSD, Joan M. Striebel, Emily E. Nelson and Raj K. Kalapatapu, Case Reports in Psychiatry, 2017, 2017, 2319094, 10.1155/2017/2319094, https://www.ncbi.nlm.nih.gov/pubmed/28251011
- Substance Use History in Behavioral-Variant Frontotemporal Dementia versus Primary Progressive Aphasia, Raj K. Kalapatapu, MD, FAPA, Kevin L. Delucchi, PhD, Sophia Wang, MD, John D. Harbison, MD, Emily E. Nelson, BA, BS, and Joel H. Kramer, PsyD, J Addict Dis, 2016 Jan-Mar, 35, 1, 36-41, PMC4720534, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4720534/
Timeline
Senior Clinical Research Associate
IQVIA
09.2021 - Current
Clinical Research Associate
PPD
02.2021 - 08.2021
Clinical Research Associate
IQVIA
01.2020 - 02.2021
Clinical Research Coordinator
Sutter Health
03.2019 - 02.2020
Clinical Research Coordinator
The Public Health Institute
12.2017 - 03.2019
Behavioral Therapist
Milestones
04.2016 - 12.2017
Administrative Research Assistant
The University of California San Francisco
11.2013 - 06.2016
Bachelor of Science - Cognitive Science
University of California Berkeley
Bachelor of Arts - Psychology
University of California, Santa Cruz
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