Data Coordinator Clinical Research

EDUCATION

POSITION

Master Business Administration, Business Marketing, LaSalle University (online)

Bachelor of Arts, Management/Human Resources, Gettysburg College Provident

RESE ARC H

John Anderson, CSA

Clinical Study Administrator, Provident Research, Inc., Jan 2017 - Current CSA Duties and Responsibilities Include:

Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines and work instructions Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File) Responds to problems and assists in implementing corrective and preventive actions

Assist in developing Project Operations Manual and other assorted project-specific documents/guidelines, as requested

Assist in providing internal communication of important clinical data and events Assists in tracking of study activities (site visits, contracts, submissions, safety, communication etc.) and documents relating to such activities

Coordinates with clinicalproject managers/leaders and site monitors for site concerns/issues Provide an organizational support for arranging investigator meetings, training meetings and safety committee meetings

WORK EXPERIENCE

Mav be involved in other tasks to support Clinical Operations and Operating Company as needed

Vendor Oversight Remediation Follow-up Lead (VOFL), inVentiv Clinical Solutions, 2008 - 2012 Senior Document Associate, PfizerAcute Remediation Project Reviewed and Assigned System analysts work on the EDMS Wyeth Legacy QC analyst work: checked hyperlinks, reviewed, corrected and uploaded documents to Pfizer SharePoint

Project Goals: Brought current Trial Master files (TME) to current Pfizer/Wyeth standard through remediation and reviewto locate all required TMF documents Name: John Anderson

Redesigned TMF process and supported infrastructure to achieve MHRA standard and included comprehensive measurement and consequence management Last Updated:June 2021

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Clinical Regulatory Associate

Provident

RESE ARC H

Team Lead- Supported the acute vendor oversight remediation project by engaging with Study team Representative for the primary purpose of follow-up and ensured completion of open remediation action items

Clinical Regulatory -Document Asso ciate

Data Management- Trial Master Files,QC/QA of database documents Site Management- Informed Consent, Confidentiality Agreements, project budget managed Oncology Group Metrics- Phase IlI first to have a site open in 30 days or less and over 50% of my sites were ready in less than the recommended 120 days from site approval date ClinicalDevelopment Associate-Study Trial Management Project/Clinical Data Management

Phase I(Neuroscience) -Alcohol Studyto assess the validity of the paradigm that allowed the equipment to be used for future drug trials

Regulatory Affairs, Consultant, Abbott Nutritional Inc., 2007- 2008 Medical Device Reporting (MDR) with excellent on time deliverables Trouble-Shoot for Workflow and System Issues to management so that they could address upgrades needed with IT and CAPA Departments

Completed Standard Operating Procedures for Database Documentation for Regulatory Affairs personnel

Reconciliation of Regulatory submissions

Regulatory Specialist, PediaMed Pharmaceutical Inc, 2004- 2007 Supplier and vendor audits-created regulatory templates and checklist for audit team Expertise with Complaint Handling Requirements

Helped coordinate all PDMA Compliance, sales training and reconciliation effortswith field sales team members

Knowledge of Regulatory Requirements for all phases of Clinical Trials, Drug Development and Medical Devices Submissions

Conducted Manufacturing Audits of our suppliers and Internal Audits of our Quality Systems Brand Development Team member for all brand-centric materials for all products Accomplished on time fulfillment of deliverables of all marketed pieces to DDMAC and updated the internal DDMAC Regulatory files

Brand Management experience with all product labeling initiatives both with electronic and paper communications, budgeting and market research Name: John Anderson

Document Control for all company Forms for sales representatives and Standard Company Procedures. Maintained and Updated all our Regulatory files Last Updated: June 2021

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Provident

Applied for in-state resident education grants and complied with all Drug Wholesaler State Licensing requirements

RESE ARC H

Key contributor in creatinga database for all referenced material for clinical trials, project management and complaint handling

Document Controlof all corporate documents and files Recall Coordinator for all communications with fieldsales and management Clinical Research Director/Coordinator, Medpace Inc, 2002- 2003 Responsible for budget preparation and negotiated pricings with vendors for final approval Project Management experience creating project scope, timelines, Cost management, quality management, communication plan, risk assessments and contingency planning Conducted Investigator Recruitment by phone and mail to potential sites and arranged through the sponsor Shipment of Drug to the sites

Cross-trained in the Regulatory/QA Department to analyze internal database audit checks Responsible for planning and execution of routine and directed audits Assuring compliance of documentation, databases, vendors and internal systems Conducted all phases of clinical monitoring- pre-study, initiation, interim monitoring and close out visits

Clinical Research Associate, Omnicare Clinical Research Inc, 2000- 2002 Expertise in post-marketing clinical trials of drug development Participated ldentifying and recruiting investigators, tracked patient enrollment and reporting serious adverse events

Senior Data Coordinator, Manager, Aventis Pharmaceutical Inc, 1999- 2000 Responsible for managing the data processors in time of transition and carried out the daily work schedules for day-to-day projects

Performed ad hoc queries

Entered cases, as well as, tracked by edit checks any corrections to database Monitored post-marketing safety data trends with respect to indications for the product insert and all adverse event occurrences of patients who used our drugs through studies or doctor prescriptions

Monitored all serious unlabeled 15-day alert cases in compliance with SOP (Standard Operating Procedures)

Prepared PowerPoint presentations for associates drug seminars Name: John Anderson

Wrote monthly reports for initial and follow-up cases that came into the department, which enabled us to understand workflow and keep in compliance with SOP Last Updated: June 2021

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