Bonnie Halperin
East Greenwich
Summary
Motivated RN with over five years of serving patients in various therapeutic indications. Eager to assist in any way, offering my in-depth knowledge of cancer. Highly motivated to offer commitment and excellent service to help patients through their healing journey.
Overview
12
12
years of professional experience
Work History
Owner and Floral Designer
Anemone Flora Bar
02.2021 - Current
- Arrange both real and dried flowers for display at special occasions.
- Collaborated with clients to design floral arrangements that realized their vision for events like dinner parties, doctor's offices, and birthdays.
- Ordered and purchased flowers and supplies from wholesalers and growers.
- Keep inventory watered, cut and fresh to ensure high quality products are delivered to clients.
- Extended excellent customer service, understanding their floral design needs and assisting with design of custom arrangements.
- Provided expert advice on designs on how to use floral products and additional items.
- Provided creative suggestions to customers through in-store demonstrations and on-the-spot arrangements, enhancing their floral experience.
- Crafted high-quality, original floral designs using diverse materials, ensuring aesthetic appeal and client satisfaction.
- Produce floral designs incorporating innovative use of colors, floral elements, containers and accent materials, while staying true to design styles and cost of goods
Sales Associate
Renova Lighting Concepts
01.2020 - 08.2022
- Created sales quotes for commercial and industrial lighting products, facilitating timely responses to customer needs
- Supported major lighting manufacturers by addressing sales inquiries and ensuring seamless communication with clients
- Delivered all approved quotes to Purchase and Sales Team
- Updated status of all generated potential sales quotes to Management team
- Updated follow-up tracker to monitor customer interactions.
- Tracked sales activities using an organized log system.
Sr. Clinical Research Associate
Premier Research
10.2019 - 01.2020
- Delivered quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Verified validity, correctness, and completeness of clinical data collected at assigned sites per ICH GCP/ISO14155, protocol, and client requirements.
- Monitored (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Conducted on-site qualification, study initiation, interim monitoring, and close-out visits at investigator sites to ensure compliance and study integrity.
- Maintained Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Had an understanding of the required essential documents according to ICH/GCP Section 8. Reviewed site documents and verified they were accurate, complete, current, and included required updates
- Communicated with study sites as directed by CMP and completed documentation of contacts in agreement with the study site.
- Ensured site visit metrics and utilization were maintained as required and escalated available time as necessary to line manager
- Ensured subject safety and delivered quality data for clients through meticulous attention to detail.
- Reviewed IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Acted as a resource for other CRAs and shared knowledge base and best practices
- Assisted with various tasks as assigned by the project manager.
Sr. Clinical Research Associate
Pharm-Olam; aligned with Orbus Pharmaceuticals
11.2018 - 08.2019
- Managed clinical monitoring activities, coordinating on-site visits and logistics, developing site recruitment plans with site staff, and ensuring compliance with ICH GCP guidelines through thorough documentation verification, data collection, and drug accountability
- Monitored patient safety on-site and promptly addressed violations to uphold study integrity
- Conducted qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits at assigned clinical sites
- Performed clinical trial monitoring and site management activities for projects, acted as a direct contact with clinical sites, and assessed overall integrity of study implementation and adherence to study protocol.
- Maintained in-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Mentored and guided CRA team members to enhance team collaboration and knowledge sharing
- Focused on managing Oncology studies at clinical sites
Sr. Clinical Research Associate II
Precision for Oncology, Medicine and Rare Disease; aligned with Oncopeptides Pharmaceutical
11.2016 - 10.2018
- Conducted all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH-GCP and Precision Oncology’s SOPs
- Performed all clinical trial monitoring and site management activities for projects, acted as the primary contact with clinical sites, and assessed the integrity of study implementation and adherence to study protocol.
- Conducted qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits at assigned clinical sites
- Managed clinical monitoring activities by arranging on-site visits and logistics, establishing site recruitment plans with site staff during QV, and ensuring completeness and quality of regulatory documentation, site verification, data collection, and drug accountability per ICH GCP guidelines
- Maintained in-depth knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, to ensure compliance throughout trials
- Established, updated, tracked and maintained study specific trial management tools/systems, and status reports
- Maintained study tracking, in accordance with the demands of the study
- Mentored and trained new employees and junior monitors to enhance team capabilities and ensure adherence to study protocols
- Focused on clinical trials in oncology, ensuring compliance with study protocols and regulations.
Clinical Trial Lead II
Chiltern
02.2016 - 11.2016
- Coordinated the development and communication of study start-up plans and project- specific procedures, guidelines, documents and forms, in line with relevant SOPs, ICH/GCP and local requirements
- Coordinated Clinical Monitoring project team and cross-functional meetings to ensure alignment and effective communication among stakeholders
- Initiated and led regular conference calls with the Clinical Monitoring project team to collect information about the study status and other study-related issues
- Set priorities for other CRAs and ensured deadlines were maintained
- Tracked and distributed clinical trial supplies to facilitate timely study initiation and ongoing operations
- Reviewed site visit reports for quality and compliance, ensuring adherence to procedures and sponsor requirements
- Prepared Lead CRA tools including the following: Task list per study phase; Monitoring visit guideline template; CRF completion guidelines, annotated visit reports, study qualification and initiation presentation template
Clinical Trial Lead
MedSource
03.2014 - 01.2016
- Provided mentoring and support to less experienced members of the project team and advice on training and quality issues
- Acted as a resource for team members regarding protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues
- Facilitated site visits and calls to enhance communication and support for project team
- Monitored enrollment status reports to maintain alignment with enrollment goals
- Conducted routine performance assessment visits for less experienced CRAs to ensure monitoring met Med Source standards
- As an approved accompanier, conducted sign-off authorization visits for new CRAs on pre-study, initiation, interim and close-out visits
- Supported Clinical Team Manager by reviewing monitoring visit reports and managing associated tasks
- Developed study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data
Sr. Clinical Research Associate
Premier Research
10.2013 - 03.2014
- Delivered quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Verified the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites according to ICH GCP/ISO14155, protocol, and client requirements.
- Monitored (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Prepared and conducted on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites.
- Maintained Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Had an understanding of the required essential documents according to ICH/GCP Section 8. Reviewed site documents and verified they were accurate, complete, current, and included required updates
- Coordinated communication with study sites per the CMP, documenting all site interactions for compliance and clarity.
- Monitored site visit metrics and communicated resource availability to line manager to align with project requirements.
- Ensured subject safety and delivered quality data through meticulous attention to detail in project monitoring.
- Reviewed IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Supported other CRAs by sharing insights and best practices from my experience in the field.
Education
Bachelor of Science - Nursing
Rhode Island College
Providence, RI01.1994
Associate Degree - Fashion/Buying and Merchandising
Fashion Institute of Technology
NYC, NY01.1984
Skills
- Patient management
- Direct patient care
- Patient assessment
- Care planning
- Medication administration
- IV medication administration
- Vaccine administration
- Wound management
- Infection control
- Chronic care management
- Clinical judgment
- Nursing process
- Safety protocols
- Documentation skills
- [Type] EMR software
- Skills training
- IV therapy
- Effective communication
- Multitasking capacity
- CPR certification
- IV therapy
Affiliations
- RI RN Multi-State Licensure, 33029, 03/01/27
- CPR Certification, 05/26
Languages
English, Spanish, Basic
Timeline
Owner and Floral Designer
Anemone Flora Bar
02.2021 - Current
Sales Associate
Renova Lighting Concepts
01.2020 - 08.2022
Sr. Clinical Research Associate
Premier Research
10.2019 - 01.2020
Sr. Clinical Research Associate
Pharm-Olam; aligned with Orbus Pharmaceuticals
11.2018 - 08.2019
Sr. Clinical Research Associate II
Precision for Oncology, Medicine and Rare Disease; aligned with Oncopeptides Pharmaceutical
11.2016 - 10.2018
Clinical Trial Lead II
Chiltern
02.2016 - 11.2016
Clinical Trial Lead
MedSource
03.2014 - 01.2016
Sr. Clinical Research Associate
Premier Research
10.2013 - 03.2014
Bachelor of Science - Nursing
Rhode Island College
Associate Degree - Fashion/Buying and Merchandising
Fashion Institute of Technology