Jonathon Wiggins Email & Phone Number

Los Gatos, California, Us

Manage and provide oversight of forecasting strategies and risk mitigation in site budget development/justification; provide cross-departmental partnership to advise on site budgets and forecastingProvide high level subject matter expertise of clinical payments to business partnersReview and analyze costs pertaining to site budget operations; verify fair market value and current clinical tasks and procedure expensesDevelop, deliver, and maintain site budget estimates during the project bidding processAnalyze and ensure accuracy of invoices for site and vendor payments from start-up through study close-out activities, including reconciliationsAnalyze, apply, and maintain contract/budget amendments in tracking system to ensure proper payments per the execution datesImplement and manage processes and site budget payments in multiple studies and therapeutic areasInterface and collaborate with frontline inquiries from sites, study team members, and other departments regarding site budgets; troubleshoot and problem solveDevelop and maintain policies, SOPs, and associated documents concerning site budgetsDrive process improvement and quality-related initiatives associated with study execution and deliverables in analysis and follow-through of site budgets

Los Gatos, California, Us

Los Gatos, California, Us

Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim and close out Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion Managing, preparing, sending, tracking, and returning investigational supplies at individual sites Monitoring and documenting investigational product dispensing, inventory, and reconciliation Monitoring and documenting laboratory sample storage and shipment Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues Reviewing data queries and listings, and working with the study centers to resolve data discrepancies Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials Following Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs

Los Gatos, California, Us

Advanced understanding and demonstration of proficiency in CTA tasks

Los Gatos, California, Us

Set-up and maintains the Trial Master File (TMF)Assists in ProTrials QA TMF review and general FDA readiness Obtains, reviews, processes and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols etc.)Creates/Develops, maintains and disseminates study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, Budget disbursements Creates/develops and maintains additional trackers including, but not limited to: Study enrollment and terminations, Serious Adverse Events (SAEs), Protocol deviations and violationsPrepares, ships, and manages inventory of study related supplies and maintains tracking information. Gathers investigator and site information (addresses, phone numbers, fax numbers, personnel names and email addresses, etc.)Assists in preparation of materials for investigator meetings, monitor workshops, and study manuals Assists Clinical Project Manager/Client in managing investigator meetingsTakes minutes of meetings with project teams, sponsors, or vendors with minimal comments Communicates effectively with members of the ProTrials/Client project team in a collaborative manner Develops credible relationships through direct interface with Client/Sponsor and disseminates study related information to project team Leads, trains, guides and/or allocates work to other CTAsProvides TMF/Regulatory Document review training for Jr. CTAsProcesses site payments and delivers monthly Projections to Client Manager, manages and investigates payment reconciliations and audit requests for client

Menlo Park, Ca, Us

Assisted with fiscal year end audit samples of A/R invoices, A/P expense reports, cash receipts, and sales journals prior to archiving files for storage.Printed and coded employee expense reports from Concur.Researched procedures with state and city government Department of Revenue, Sales Tax and/or Business Registration divisions for process related to changing a company's name.

Fremont, Ca, Us

Managed the Purchasing Department and coordinated the delivery of production materials with Shipping/Receiving.Obtained quotes from vendors, generated purchase orders, created and maintained tracking logs of orders and material prices, approved A/P invoices, resolved billing discrepancies, and created the Purchasing Department manual.Monitored stock inventory, assessed weekly production requirements, and developed new vendor contracts.Visited vendor companies to examine facilities, evaluate processes, and discuss variances in material fabrication.Confirmed job cost data, updated budget changes, analyzed forecasting for cost control, evaluated projected completion costs compared to original estimates, and communicated budget issues with project leads and operations management.Awarded and negotiated material orders with vendors that produced a job cost savings of $30K on a single order for one client, and more than $100K on an entire project encompassing eight months of production.

Cambridge, Ma, Us

Performed data verification visits at clinical study facilities, reconciled database entry with recorded patient-study procedures, and reported discrepancies to all applicable parties at the study site, clinical vendors, project managers and the study sponsor’s operations team;Tracked patients’ study progression including scheduled clinic visits, lab results, and compliance with individual treatment regimens through remote, electronic diary input and database entries;Composed field-visit reports for clinical trials detailing protocol deviations, material inventory, dispensation and disposal records, and regulatory documents collected for the master-study files in preparation of FDA audits;Assisted clinical-site staff with review board submission packages for investigational study participation approval, provided sponsor-protocol training, and coordinated delivery of all required lab materials to conduct the research in accordance to FDA regulations and the sponsor’s study design;Attended key operation meetings to review the clinical study progress metrics, and any developments that would warrant discussion of study design revisions and amendment changes;Awarded two contract extensions and assigned as a team lead for international meetings at Biogen Idec.

Vancouver, British Columbia, Ca

Scheduled advisory board meetings, coordinated travel and hotel arrangements, distributed agenda details and meeting packets, organized catering, attended event sessions to facilitate guest needs and record/distribute meeting minutes.Created poster presentations for industry conferences, ordered office supplies, submitted facility requests and equipment requisitions, prepared employee and guest travel-expenses, and coded/prepared invoices for payment via the Finance Department.Maintained department’s intranet website with published research documents as well as event announcements and staff updates.Supported the Center for Disease Control food safety program with application/license processing and database maintenance.

Newark, New Jersey, Us

Provided direct support to Vice Presidents, Directors and senior managers in addition to performing Receptionist tasks that encompassed operating a multi-line switchboard, managing conference room calendars, ordering/receiving office supplies, greeting guests, submitting building/maintenance requests and mailroom duties.Created PowerPoint meeting presentations, managed VP’s calendars, prepared expense reports for managers and guests, organized travel arrangements, set-up travel profiles, assembled quarterly marketing report mass mailings, and facilitated offsite file retention.Managed the employee transit-voucher program, planned and coordinated employee events, and researched and negotiated new vendor companies and alternative services for the office.Independently investigated and resolved invoices and dormant accounts resulting in reconciled charges that favorably negated accrued fees.

Medical Terminology Ii: A Focus On Human Disease

Education record

Education record

Cra Training Series

Medical Terminology: A Word Association Approach