Jared Welsh Email & Phone Number

New Windsor, MD, US

Morrisville, NC, US

Associate Global Trial Manager

Morrisville, NC, US

Clinical Trial Manager

Wilmington, NC, US

• Recent 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)

Wilmington, NC, US

• Same 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.

Wilmington, NC, US

• Same 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

Wilmington, NC, US

• Same 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)

Wilmington, 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

Wilmington, 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.
• 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

Wilmington, 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