Experience

Promedica International, A California Corporation

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Document Administrator

  • Oct 2021 - Present

  Costa Mesa, California, United States

• In-House CRA/Clinical Document Administrator

  • Apr 2021 - Oct 2021

  * Acts as site resource and when monitor is not available * Responsible for management of study Trial Master Files. * Develops new eTMF filing structures using PMI or sponsor-preferred format. * Organizes, prepares, and ships study supplies to clinical sites(regulatory binders, questionnaires, etc.) * On-line or manual review of Case Report Forms with query review for validity/comprehension. * Communicates with monitors and data managers as necessary to generate and respond to… Show more * Acts as site resource and when monitor is not available * Responsible for management of study Trial Master Files. * Develops new eTMF filing structures using PMI or sponsor-preferred format. * Organizes, prepares, and ships study supplies to clinical sites(regulatory binders, questionnaires, etc.) * On-line or manual review of Case Report Forms with query review for validity/comprehension. * Communicates with monitors and data managers as necessary to generate and respond to queries efficiently. * Maintains study trackers and logs for site enrollment, visit schedules, protocol deviations. adverse events monitoring visit schedules, monitoring visit outstanding action items. * Trends and summarizes deviations by site, category, and frequency rate. * Assists in communications with data management group as necessary. Participates in data line listing review and data cleaning prior to data locks. * Updates site file regulatory document logs monthly and assist in communicating regulatory document deficiencies to the on-site monitors. * Ongoing interface with Clinical Research Associate(s) or site study coordinator(s) to monitor subject enrollment progress * Provides regular updates to Promedica regarding study clinical monitoring issues, sponsor communications, and data reviewed from designated sites. * Assists with analysis and development of study-related reports. * Assists Project Manager with GCP audits or training programs. Assists in site budget negotiations. * Prepares initial IRB submissions for review by Project Manager. Participates in project management plan development/review. * Participates in the preparation of monitoring plan & SOP development/review. * Prepares initialand subsequent drafts of Study Reference Manual and associated forms and attachments. * Participates in site visit reports log-in/review/follow-up.



TransPerfect

• United States
• Translation and Localization
• 700 & Above Employee

• Solutions Architect II

  • Sep 2020 - Apr 2021

  Zebulon, NC, United States • Work in partnership with operations for configuration of Trial Interactive enterprise software and solutions • Designs and documents new configurations and solutions for Trial Interactive software • Creates and maintains User Requirements Specification and Configuration Specifications for implementing customers as part of the onboarding process • Acts as the product configuration and domain expert in all relevant sales cycles with specific responsibility for demonstrating the product… Show more • Work in partnership with operations for configuration of Trial Interactive enterprise software and solutions • Designs and documents new configurations and solutions for Trial Interactive software • Creates and maintains User Requirements Specification and Configuration Specifications for implementing customers as part of the onboarding process • Acts as the product configuration and domain expert in all relevant sales cycles with specific responsibility for demonstrating the product to prospects and existing customers • Collaborates with sales on requirements gathering and software configurations for demonstrations and respond to functional and technical questions • Serves as a conduit between the Sales team and Operations and Product teams, clearly conveying customer/prospects and business requirements from the field to the Operations and Product teams • Develops and scripts product and solution demonstrations • Disseminates the Trial Interactive vision through product demonstrations, webinars/seminars, conferences and account specific initiatives • Aids in the drafting and review of Standard Operating Procedures (SOP) in order to meet departmental and QA guidelines and initiatives Show less



Treximo (A ProPharma Group Company)

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Clinical Operations Specialist

  • Apr 2020 - Sep 2020

  Durham, North Carolina, United States • Responsible for providing document management and clinical operations systems support to the Treximo Clinical Operations Team and reports to the Vice President, Clinical Operations • Completes new trial setup in Clinical Trial Management System (CTMS) and in the electronic Trial Master File (eTMF) systems • Participates in clinical systems implementations as the document management subject matter expert (SME) • Serves as the department ‘superuser’ of eTMF and provides eTMF training… Show more • Responsible for providing document management and clinical operations systems support to the Treximo Clinical Operations Team and reports to the Vice President, Clinical Operations • Completes new trial setup in Clinical Trial Management System (CTMS) and in the electronic Trial Master File (eTMF) systems • Participates in clinical systems implementations as the document management subject matter expert (SME) • Serves as the department ‘superuser’ of eTMF and provides eTMF training to new users and study team members • Provides document management support to clinical teams during study startup and other periods of high-volume document flow as assigned • Tracks and prepares department information utilizing databases, spreadsheets, and other tools • Participates in TMF SOP reviews and ensures TMF QC process is managed across all trials • Manages and tracks study-specific contracts and clinical study payments in applicable systems • Manages and tracks clinical and non-clinical supplies, including purchase and shipping • Assists with the development and distribution of site binders • Set-up and coordinate meetings, take and distribute meeting minutes Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Trial Master File Lead

  • Jun 2019 - Mar 2020

  Raleigh-Durham, North Carolina Area • Manages the Trial Master File (TMF) for 11 clinical trials; responsible for set-up, maintenance, and closeout/shipment of assigned studies • Configures completeness reports and sponsor/project specific TMF reports, and develops the list of expected documents and the gap analysis • TMF Subject Matter Expert (SME); communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF • Collaborates with the Project Team to ensure TMF… Show more • Manages the Trial Master File (TMF) for 11 clinical trials; responsible for set-up, maintenance, and closeout/shipment of assigned studies • Configures completeness reports and sponsor/project specific TMF reports, and develops the list of expected documents and the gap analysis • TMF Subject Matter Expert (SME); communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF • Collaborates with the Project Team to ensure TMF documentation is submitted and published in a timely manner and with high quality in order to maintain the TMF in an audit-ready state • Designs and delivers study specific TMF training in various formats via teleconference, video conference, and/or in person • Participates in audits/inspections and prepares for audits to ensure audit-readiness for the TMF • Generates Completeness Reports and inspection readiness metrics, as well as provides regular feedback/training to the Project Team on TMF health/status • Identifies TMF best practices and leads/participates in TMF process improvement initiatives Show less



DOCS

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Clinical Project Manager/CTS for Amgen

  • Apr 2018 - Jun 2019

  Durham, North Carolina • Facilitated authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list • Prepared Clinical Study Team (CST) meeting agendas and minutes • Quality checked and submitted documents to Trial Master File (TMF) in Veeva Vault • Provided administrative support for the Global Project Team • Responsible for coordination and management of study vendors • Created and managed study specific tools such as recruitment and… Show more • Facilitated authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list • Prepared Clinical Study Team (CST) meeting agendas and minutes • Quality checked and submitted documents to Trial Master File (TMF) in Veeva Vault • Provided administrative support for the Global Project Team • Responsible for coordination and management of study vendors • Created and managed study specific tools such as recruitment and retention materials and study newsletters • Managed process for planning and procuring equipment and ancillary clinical supplies • Compiled and submitted IRB/EC submission documentation • Contributed to the preparation of training materials (Investigator Meetings/Site Initiation Training) • Managed global versioning and distribution of informed consent forms (ICFs) • Coordinated study required vendor access to applicable systems (IXRS/Bioclinica/Medidata/SharePoint) • Managed quarterly eTMF quality review for global study • Compiled study level reports for distribution to study team members • Facilitated and managed Study Management Associate (SMA) requests Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Trials Assistant

  • May 2016 - Apr 2018

  Durham, North Carolina • Tracked and reconciled eDiary issues with sites in coordination with CTM and Sponsor • Served as Global CTM support CTA preparing, analyzing, and consolidating weekly Error Capture Tool (ECAT) Source Document Review (SDR) Compliance Reports for 2971 sites in 36 countries in support of Quality Regional Risk Review Meeting (QRRM) initiative to reconcile global SDR backlog and maintain ECAT/SDR compliance • Ordering, dispatched, and tracked study team retention and site support… Show more • Tracked and reconciled eDiary issues with sites in coordination with CTM and Sponsor • Served as Global CTM support CTA preparing, analyzing, and consolidating weekly Error Capture Tool (ECAT) Source Document Review (SDR) Compliance Reports for 2971 sites in 36 countries in support of Quality Regional Risk Review Meeting (QRRM) initiative to reconcile global SDR backlog and maintain ECAT/SDR compliance • Ordering, dispatched, and tracked study team retention and site support materials • Composed meeting minutes utilizing proper grammar, punctuation and proofreading to record outcomes • Assisted CPM with site management activities such as review of monitoring reports, tracking of site visits, communication with CRAs, and other activities as assigned • Organized and maintained tracking systems and tools to support the conduct of a clinical study from start-up to close-out • Created spreadsheets, trackers, presentations and documents to meet study needs • Organized and prepared files related to study tracking, reporting and submitted to sponsor(s) TMF within established guidelines • Quality checked, filed and reconciled TMF for multiple clinical trials • Maintained and organized clinical study documents (i.e. 1572s, CVs, IRB-IEC documents such as approvals, renewals, membership list and other study agreements) • Uploaded external and internal clinical documents into eRoom database; maintained room structure withappropriate naming convention Show less



U.S. Department of Veterans Affairs

• United States
• Government Administration
• 700 & Above Employee

• Medical Reimbursement Technician

  • May 2014 - Apr 2016

  Greater Nashville Area, TN • Verifies benefits, policy number, pre-certification requirements, Insurance contact information, and effective dates of for Veterans' insurance coverage for inpatient and outpatient services • Validates claims for billing purposes ensuring eligibility and referring questionable coding for review



Tennessee Emergency Management Agency

• United States
• Government Administration
• 1 - 100 Employee

• Public Assistance Liaison

  • Mar 2013 - May 2014

  Greater Nashville Area, TN • Responsible for disaster recovery for 21 counties and all state agencies in Tennessee • Maintained personal contact will all responsible applicants to include site visits to ensure all recovery needs are met • Assisted disaster applicants with all aspects of recovery to include federal and state inspections, payments, form completion • Closed recovery process for 50 applicants from 4 different disasters • Processed 48 grant contract amendments for 4 different disasters



United States Air Force

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Health Services Manager

  • Mar 1992 - Mar 2013

  • Demonstrated expertise leading medical readiness training programs and deployment operations for 324 hospital members • Expertly managed Patient Administration flight plans/programs and $20K budget, while leading 17 personnel who serviced 2.6K medical beneficiaries and 23K clinic visits per year • Efficiently managed HIPAA program, achieved 99% compliance rate during command consultative visit, and program excellence lauded by inspector • Recognized for exemplary management of… Show more • Demonstrated expertise leading medical readiness training programs and deployment operations for 324 hospital members • Expertly managed Patient Administration flight plans/programs and $20K budget, while leading 17 personnel who serviced 2.6K medical beneficiaries and 23K clinic visits per year • Efficiently managed HIPAA program, achieved 99% compliance rate during command consultative visit, and program excellence lauded by inspector • Recognized for exemplary management of Medical Evaluation Board program, process was adopted by two command bases, and achieved 100% on-time submission of cases for 10 consecutive months • Skillfully trained 109 geographically separated unit personnel on patient movement process, while contributing to 75% reduction in patient movement errors Show less