Aaron Ellis

Accomplished Document Manager

Establishes Optimal and Secure Clinical Record Systems

Extensive experience in essential document collection, review and maintenance and auditing study files. Background includes 20 + years’ experience in FDA-regulated environments, including both hard and electronic studies and internal / external client service. Recognized as dedicated team player, that volunteers to take on additional tasks that enable achievement of challenging delivery goals.

Professional Development

Heron Therapeutics, San Diego, CA 2016-2023

Senior Clinical Systems and Records Management Specialist

Serves as an experienced Subject Matter Expect for Clinical Systems (e.g. CTMS and eTMF) and provides leadership support for clinical system set-up, user account management and review, ongoing maintenance, closure and archival activities.

Support the study team to define, create and generate specific Clinical System reports and assist the Clinical Study Team with accurately updating and maintaining clinical systems and processes that track site and study conduct, compliance and performance within project timelines.

Assist and provide operational input to the clinical team in the preparation, filing, and archiving of the Trial Master File documentation and reports according to the scope of work, Trial Master File Plan and standard operating procedures.

Lead the periodic review of the Trial Master File, in close collaboration with the Study Manager, and assess for completeness, communicating trends and supporting GCP inspection readiness activities.

Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF).

Assist with Clinical System Change Control activities including performing User Acceptance Testing activities.

Assist with study start-up activities and tracking study metrics (e.g. feasibility data, ICF review, and Trial Master File (TMF) tracking).

Collect, track and conduct secondary review for completeness of site regulatory documents for Investigational Product (IP) release.

Assist with the development of study tools and templates for clinical trial start up activities including providing input into the Trial Master File Plan

Assist with the organization of internal team meetings, investigator meetings and other trial-specific meetings including taking meeting minutes, where required

Support the development, creation and shipping of site specific Investigator Site File, Pharmacy Binders and other site supplies, as required.

Communicates directly with sites, Site Management Organizations (SMOs), Contracted Vendors and field CRAs, where required, to obtain updated information, essential documents to assist with driving start-up, study conduct, and/or close out activities

May accompany CRAs on site visits to assist with Investigator Site File review.

Serves as an experienced role model and mentor others on specific tasks, systems or processes and sharing lessons learned while interacting in a positive professional manner.

Support departmental process improvement efforts.

May perform other assigned administrative duties to support team members with clinical trial execution.

Veeva Vault Owner

Train all CTMS/eTMF Veeva users

User Access (setup/removal)

Site Set-up (CTMS/eTMF)

Change Control

Monthly Reporting

Document maintenance (reclassification, editing and removal), in accordance and guidance of the DIA Reference Model.

Unblinded - Clinical Trial Assistant

Prepare general correspondence with minimal direction

Provide support for clinical study managers, clinical research associates (CRA), and trial sites.

Work with legal and accounts payable to keep legal/financial records and signoffs current.

Assist with collection of essential documentation from the clinical sites and in-house management of site essential documents. Making sure and applying ALCOA standards.

Assemble essential regulatory document packages for review and eventual submission to regulatory for site start up activities.

Preparation and shipment of study initiation binders / materials and trial supplies to the site.

Assist in maintenance of paper and electronic filing system for department documents. Utilize Drug Information System file structure.

Design and manage various tracking systems for study sites, CRAs, and other clinical activities.

Maintain timely and effective communication with team members, vendors and site staff.

Provide support to special projects

Manage multiple tasks and demands upon request of the team.

Serve as backup to document management system super-user

Provide quality review checks of documents, reports, and other clinical materials.

Experience in eTMF/TMF reconciliation of global studies

Supports all project activities for filing and maintaining the Clinical eTMF/TMF

Update and maintain all clinical trackers related to the Clinical Study Team

Ionis Pharmaceutical, Carlsbad, CA 2015-2016

Clinical Trial Assistant

•Trial Master File specialist to reconcile study related documents

•Knowledge of GCP Part 8 – Essential Documents for the Conduct of a Clinical Trial

•Experience in TMF reconciliation of global studies

•Supports all project activities for filing and maintaining the Clinical TMF

•Ensures all required documentation is filed in the Investigator TMF

•Update and maintain all clinical trackers related to the Clinical Study Team

•Attend meetings, taking notes and the distribution of meeting minutes

Sigma Aldridge/SAFC, Carlsbad, CA 2014-2015

Document Control QA/QC

•Assemble Document Change Order packages

•Incorporate revision comments

•Ensure version control for all documents and forms

•Make effective and distribute controlled documents

•Perform technical writing function as required

•Lead or support document control systems improvements

•Order packages Incorporate revision comments

•Ensure version control for all documents and forms

•Notification of new approved documents

•Perform technical writing function as required

•Assist department head with revision to internal Document Control

QUINTILES, San Diego, CA 2008 – 2014

Document Control Specialist II

•Function as Team Lead for records management projects.

•Ensure project deadlines, commitments, and goals are met by monitoring team’s daily outputs.

•Train team members on records management tasks, policies, and procedures.

Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within agreed timelines.

•Conduct and manage imaging/scanning processes and train staff on imaging/scanning processes. Interface with departments to support retrieval projects and ensure information needs are met.

•Serve as primary contact for internal and external clients.

•Maintain records center security to protect record integrity by ensuring compliance to SOPs.

•Design and administer records management systems and processes.

•Record retention, archiving and file box review.

BIOGEN IDEC, San Diego, CA 2002 – 2007

Clinical Associate II

•Establish & maintain practical medical filing system

•File product, protocol and investigator documents in a timely manner

•Perform internal audits

•Establish and maintain secure systems for CT scan and archival and retrieval

•Establish and monitor procedures to ensure tracking and return of all documents for clinical study reports

•Support clinical documentation in assembling documents for clinical study reports

•Establish and maintain security procedures for all CMF documents

•Develop electronic filing and document systems to provide controlled, efficient, and manageable growth of the CMF tracking systems

•Scan, index and assign attributes for entering documents into Documentum

Education

Diploma, Mount Miguel High School, Spring Valley, CA

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