Rachel B. Email and Phone Number
Rachel B. work email
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Rachel B. personal email
With over 10 years of experience in clinical research, I am a start-up expert who leads and supports teams to deliver high-quality and efficient clinical trials. I have been recognized for my excellence and innovation in start-up management, winning the PharmaTimes CROY Gold Award and the Citeline Award for Clinical Research Team of the Year. I have strong skills in data analysis, risk assessment, process improvement, and stakeholder communication, and I am passionate about advancing science and improving patient outcomes.
Thermo Fisher Scientific
View- Website:
- thermofisher.com
- Employees:
- 99360
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Principal Start-Up Team ManagerThermo Fisher ScientificRaleigh, Nc, Us
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Area Study Start Up LeadAbbvie Nov 2024 - PresentNorth Chicago, Illinois, Us -
Principal Start-Up Team ManagerThermo Fisher Scientific Apr 2023 - Nov 2024Waltham, Ma, Us
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Senior Start-Up Team ManagerThermo Fisher Scientific Dec 2021 - Apr 2023Waltham, Ma, Us
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Senior Start-Up Team ManagerPpd May 2021 - Apr 2023Wilmington, Nc, Us -
Sia Trial ManagerPpd Jul 2019 - May 2021Wilmington, Nc, Us
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Senior Country Approval SpecialistPpd Nov 2016 - Jul 2019Wilmington, Nc, UsPrepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable), in alignment with global submission strategy. Develops and implements local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Primary contact for investigators and for the local regulatory to ensure submissions are managed in a timely manner. Act as a key-contact at country level for all submission-related activities and participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. Ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Prepare the regulatory compliance review packages, as applicable, as well as liaise within the start up team locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. In addition, develop the country and sites specific Patient Information Sheet/Informed Consent form documents.
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Country Approval SpecialistPpd May 2015 - Nov 2016Wilmington, Nc, UsUnder guidance prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications as applicable), in alignment with global submission strategy. Coordinate, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Have contact with investigators for submission related activities and serves as key-contact at country level for either Ethical or Regulatory submission-related activities and achieves PPD’s target cycle times for site. Prepare the regulatory compliance review packages, including working with the SIA CRA as applicable, Develop country and site specific Patient Information Sheet/Informed Consent form documents.
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Clinical Research CoordinatorThe Institute For Asthma & Allergy, P.C. Sep 2013 - May 2015Coordinate pediatric and adult clinical trials in asthma, allergy, and immune disorders. Direct the conduct of clinical trials to ensure strict adherence to the research protocol. Responsible for screening patient records, databases, and physician referrals for correct identification of possible candidates. Manage all regulatory and IRB submissions. Actively monitor patients’ study progress to fulfill protocol and sponsor requirements. Conduct patient study enrollment, informed consent process, and proper scheduling of follow-up visits. Ensure all data is collected, documented, and submitted for patient visits. Perform routine ECGs, phlebotomy, pulmonary function tests, allergy testing, and lab processing. Adherence to IAA standard operating procedures, HIPPA, GCP, FDA, and sponsor’s requirements and regulations. Committed to ensuring patient health and well-being is the top priority.
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Clinical Research CoordinatorNeuroscience, Inc. Jul 2013 - Sep 2013Coordinate pediatric and adult clinical trials in ADHD, depression, generalized anxiety, autism, and binge eating disorder. Primary duties consist of recruitment and marketing of all clinical studies. Participation in data collection, patient scheduling and consent, regulatory documentation, and acquiring all other laboratory data from study subjects. Trained in Good Clinical Practice (GCP), Dangerous Good Shipping (IATA/DOT), and phlebotomy.
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Research TechnicianTechlab Jan 2012 - Jul 2013Blacksburg, Va, UsPerform a panel of molecular and microbiological assays on samples received from off site hospitals and clinics. Manage multiple projects.Work independently and within a team environment. Organize and summarize data, then communicate results and findings to team. Optimize, troubleshoot, and assess assay performance. Perform statistical data analysis on individual assay performance as well as large population groups. Review, edit, and write abstracts being prepared for presentations at scientific conferences. Adhere to all Federal Regulations (FDA and USDA). -
Research AssistantRadford Arbovirus & Medical Entomology Laboratory Aug 2009 - May 2011Performed undergraduate research under the supervision of Dr. Justin Anderson. Analyzed the effects of coffee on Aedes albopictus and La Crosse virus, using a variety of advanced experimental techniques. Generated and interpreted the data for creation of posters and presentations. Successfully identified that coffee in certain concentrations may prevent transmission of La Crosse virus by Aedes albopictus. Results are published in the Frontiers in Systems Biology (2012).
Rachel B. Skills
Rachel B. Education Details
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Radford UniversityBiology
Frequently Asked Questions about Rachel B.
What company does Rachel B. work for?
Rachel B. works for Thermo Fisher Scientific
What is Rachel B.'s role at the current company?
Rachel B.'s current role is Principal Start-up Team Manager.
What is Rachel B.'s email address?
Rachel B.'s email address is ra****@****ppd.com
What schools did Rachel B. attend?
Rachel B. attended Radford University.
What skills is Rachel B. known for?
Rachel B. has skills like Teamwork, Clinical Research, Project Management, Data Analysis, Success Driven, Close Attention To Detail, Conceptualization, Public Speaking, Written And Oral, Time Management, Written And Oral Presentation Skills, Collaboration.
Who are Rachel B.'s colleagues?
Rachel B.'s colleagues are Sarah Truax, Csm®, Mary Clarence Sobremisana, Patrick Moore, Elise Martin, Natacha Glisse, Luca Pozzoli, Abhishek Patel.
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