Jared Welsh work email
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Jared Welsh personal email
Prior to Syneos Health, over 9 years at PPD from Project Assistant to Principal/Lead CRA. Eight years experience as a Clinical Research Associate on six HIV-1 studies and one HIV-1 Prophylaxis study, Phases II and III, Double-Blind and open-label, adult and pediatric populations. Lead CRA on COVID-19 Remdesivir studies. Recent achievements (as of May 2020): - Lead CRA on the unprecedented COVID-19 Remdesivir clinical research studies (March 2020 - May 2020). - Demanding work schedule including 12-16 hour days, 7 days a week - Project/Clinical management responsibilities assigned to include direct sponsor communication - Primary point of contact for Global Pandemic drug resupply (focused on mitigating drug shortage)Study Leadership Team accomplishments: - 100+ sites activated - Thousands of patients successfully enrolled - Interim analysis completed within 6 weeks of study start-up - Delivery of data for initial FDA Approval of Remdesivir announced 01 May 2020
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Project ManagerSyneos HealthNew Windsor, Md, Us
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FounderSuits For Success Md Sep 2022 - Present -
Project ManagerSyneos Health Sep 2021 - PresentMorrisville, Nc, UsAssociate Global Trial Manager
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Clinical Operations LeadSyneos Health Jul 2020 - Sep 2021Morrisville, Nc, UsClinical Trial Manager
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Principal/Lead CraPpd Apr 2020 - May 2020Wilmington, Nc, UsRecent achievements: • Lead CRA on the unprecedented COVID-19 Remdesivir clinical research studies (March 2020 - May 2020). • Demanding work schedule including 12-16 hour days, 7 days a week • Project/Clinical management responsibilities assigned to include direct sponsor communication • Primary point of contact for Global Pandemic drug resupply (focused on mitigating drug shortage) -
Senior Cra (Level Ii)Ppd Apr 2018 - Apr 2020Wilmington, Nc, UsSame as Senior CRA (Level I) with additional responsibilities: • Completed the Global Monitoring Development Training Programs (internal program by referral only)• Participated in Sponsor Inspections with no major issues noted• Performed routine performance visits for under performing CRAs (line management level duties) • Performed combination of 100% and reduced monitoring• Trained in Risk Based Monitoring. • Sites achieved top enrollment rates in limited enrollment period on HIV-1 Prophylaxis study
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Senior Cra (Level I)Ppd Apr 2016 - Mar 2018Wilmington, Nc, UsSame as CRA (Level II) with additional responsibilities: • Attended Lead CRA Training Program • Performed numerous CRA Authorization visits via the Certified Accompanier Program. • Mentored numerous peers via the Peer-to-Peer mentor program
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Cra (Level Ii)Ppd Apr 2015 - Mar 2016Wilmington, Nc, UsSame as CRA (Level I) with additional responsibilities: • Managed 22 separate sites/institutions (full travel) while still meeting all client deliverables with proper quality • The study management team delegated the responsibility to review monitoring visit reports of my peers (typically only reviewed by study management)
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Cra (Level I)Ppd Aug 2013 - Apr 2015Wilmington, Nc, Us• Developed and attended the first ever Company CRA Academy. This Academy has since grown at the Company and is highly recognized for training new CRAs. • Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations, and Company/Sponsor SOPs. • Conducts site visits to assess protocol and regulatory compliance and manages required documentation (initiation, interim monitoring and close-out) • Ensures that data will pass international quality assurance audits• Attend sponsor calls and internal team calls to stay informed of current study issues• Develop collaborative relationships with investigative sites, client company personnel and study vendors
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Research Coordination SpecialistPpd Oct 2012 - Aug 2013Wilmington, Nc, Us• Coordinate, oversee and complete all administrative functions on assigned trials, to include, but not limited to, review and transmission of regulatory documents, QC and QA of all project reports, tracking forms, and oversight of all mass mailings and faxes• Maintain knowledge of project protocol and implement project plans within specific guidelines• Accountable for meeting applicable project timelines in accordance with the contract• Mentor the research and project teams in the preparation and execution of all clinical administration functions• Assist in the training of PAs and assist management in determining training needs of the administrative staff• Ensure files are audit ready
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Project Assistant, Clinical ManagementPpd Jun 2011 - Oct 2012Wilmington, Nc, Us• Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client• Performed investigator file reviews and logged outstanding issues in project related tracking tools• Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner• Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines• Oversaw the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other functional departments
Jared Welsh Skills
Jared Welsh Education Details
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Iona UniversityMathematics
Frequently Asked Questions about Jared Welsh
What company does Jared Welsh work for?
Jared Welsh works for Syneos Health
What is Jared Welsh's role at the current company?
Jared Welsh's current role is Project Manager.
What is Jared Welsh's email address?
Jared Welsh's email address is ja****@****pdi.com
What schools did Jared Welsh attend?
Jared Welsh attended Iona University.
What are some of Jared Welsh's interests?
Jared Welsh has interest in Track, Cross Country.
What skills is Jared Welsh known for?
Jared Welsh has skills like Clinical Research, Ctms, Clinical Trials, Clinical Monitoring, Microsoft Office, Gcp, Project Management, Cro, Protocol, Quality Assurance, Regulatory Affairs, Research.
Who are Jared Welsh's colleagues?
Jared Welsh's colleagues are Gabrielle Morello, Angelique Rudi, Dharmendra Kumar, Regina Tridenti, Azer Aylin Açıkgöz Hein, Eric Morasse, Jennifer Brunner.
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