Juliette Reinhardt
Philadelphia,,Pennsylvania
Summary
Highly motivated, detail-oriented, clinical research professional with a passion for biotechnology and health equity. Current Clinical Research Associate seeking transitional opportunities within the biopharmaceutical space, with the ability to gain leadership development. Looking to expand knowledge on drug development projects, and to foster independent skills learned through working in clinical research. Experience in various therapeutic areas including vaccines, infectious diseases, Diabetes, dermatology, pain management, and Alzheimer's disease.
Overview
4
4
years of professional experience
Work History
Clinical Research Associate
IQVIA
10.2022 - Current
- Responsible for 20 US Sites across various therapeutic areas, in phase III/IV clinical trials.
- Experience in diabetic, weightloss, pain management, dermatology, and Alzheimer's therapies.
- Administers protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Manages 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.
- Communicates directly with the sponsor in order to meet data review requirements, audit inspection readiness, and ensure trial milestones are being met by the site.
- Assists in SAE reporting and applicable IRB submissions as needed.
- Meets monthly productivity metrics for monitoring requirements, report writing, and site/sponsor communications.
Clinical Research Associate
ICON plc
06.2022 - 10.2022
- Responsible for primary monitoring for US sites in a phase III, Influenza vaccine study.
- Experienced in conducting Pre-study site visits, Site Initiation visits, and routine monitoring visits.
- Ensured that entry timeline requirements are being met.
- Responsible for Investigator Site File and TMF reconciliation.
- Monitored site performance and recruitment
- Routinely checked site staff training and utilizes sponsor training systems.
- Provided support to study teams, both on site and remotely.
- Reported adverse events and serious adverse events in a timely manner.
- Wrote trip reports and follow-up letters to ensure quality communication between the sponsor and site.
- Oversaw overall protocol compliance, and serves as main point of contact for any site inquiry.
- Adhered to IRB.
In-House Clinical Research Associate
ICON plc
12.2021 - 06.2022
- Supported monitoring of a Phase III pediatric COVID-19 vaccine study.
- Provided support to sites and other CRAs directly to process and resolve queries and requests as needed.
- Served as primary in-house contact for sites and investigators participating in studies.
- Conducted and completed remote site management activities, with support as needed, according to applicable SOPs and the Study Monitoring Plan.
- Contacted clinical sites for specific requests, including; enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action item resolution or other sponsor specific tasks.
Clinical Trial Assistant
ICON plc
06.2021 - 12.2021
- Supported monitoring of several COVID-19 vaccine clinical trials.
- Provided administrative and project tracking support to clinical trial teams.
- Trained in ICH GCP, appropriate regulations, ICON SOPs, and Client SOPs/Client systems.
- Assisted in data collection and quality control of clinical study documentation.
- Ensured that clinical sites are inspection ready, assist with site audit preparedness.
- Utilized sponsor-specific systems and trainings for study file management.
- Served as a contact for clinical sites.
- Fulfill basic requests including enrollment updates, missing documentation, meeting arrangements, and report distribution.
- Collaborated with internal and external team members.
- Responsible for daily report exports.
Project Coordinator
Merck
10.2020 - 06.2021
- Educated on quality standards of pharmaceutical environment
- Trained in cGMP and SOP documentation, as regulated by the FDA.
- Processed laboratory and clinical data in reporting systems.
- Communicated with laboratory scientists often to ensure data collection processes were being met, and archival requirements were followed.
- Worked independently on various drug-related projects.
- Assisted in a company-wide merge of women's health drug related projects.
- Became skilled at reading and interpreting scientific documents and Standard Operating Procedures.
Education
Bachelor of Science - Biology & Spanish
Ursinus College
Collegeville, PA05.2020
Skills
- Microsoft Office (Word, Excel, PowerPoint, Publisher, Teams, Outlook)
- Clinical Monitoring Softwares including: Veeva Vault, Oracle systems, ICOTrial, Box, CAL, INFORM, Florence, MSB, Signant Health, Operational Metrics Repository, Firecrest, Clario, Complion, StudyHub, Preclarus, Medable and YPrime
- Customer Service: Strong interpersonal skills with 7 years of customer service experience Experience in maintaining clinical site to sponsor relationships
Timeline
Clinical Research Associate
IQVIA
10.2022 - Current
Clinical Research Associate
ICON plc
06.2022 - 10.2022
In-House Clinical Research Associate
ICON plc
12.2021 - 06.2022
Clinical Trial Assistant
ICON plc
06.2021 - 12.2021
Project Coordinator
Merck
10.2020 - 06.2021
Bachelor of Science - Biology & Spanish
Ursinus College