Laura Morrison
Overview
27
27
years of professional experience
5
5
years of post-secondary education
Work History
Senior TMF Specialist
Chimerix, INC
07.2023 - 10.2025
- Participate in the Quality Control of documents submitted to the eTMF.
- Maintain awareness of study events and the associated documentation requirements through collaboration with the TMF Manager/Lead and the Study Team (including CRO if appropriate).
- Perform essential document review ensuring sponsor obligations are being met and follow applicable regulatory, ICH/GCP guidelines and SOPs.
- Assist in review of regulatory and other essential documents for completeness and accuracy, initiating follow-up as needed for issues and deficiencies.
- Complete TMF reviews to ensure timeliness and completeness at various milestones of the study, including close-out and pre-inspection review.
- Assist with various departments during FDA inspection activities.
Senior TMF Specialist
Arcus Biosciences, Inc
07.2022 - 06.2023
- Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF.
- Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs.
- Review and classify documents collected from internal and external sources.
- Reconcile essential documents to avoid duplication.
- Support study teams with the TMF quality review process.
- Perform QC and maintenance of eTMF for assigned studies.
- Perform data entry and reconciliation in various clinical systems and tracking tools.
- Provide input on the revision of TMF-related Work Instructions and SOPs.
- Support the management and oversight of the CRO study-specific trial master files.
- Support the coordination of the transfer of study-specific trial master files from the CRO.
- Follow up on quality findings.
- Manage paper document filing process for wet-signed documents, including QC review and paper/electronic filing.
- Participation in audit, inspection readiness preparation, and inspection activities as needed.
- Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF.
- May provide training and mentoring activities for new and current staff.
- Develop metrics, reports, and TMF tools/training.
- Act as stand-in leading team meetings, managing team tasks as needed.
Sr. TMF Specialist
Daiichi Sankyo
07.2021 - 07.2022
- Act as main sponsor point of contact for the trial master file activity for multiple oncology studies.
- Provide guidance and training to both internal sponsor and external CRO teams.
- Utilize reports and dashboards within Veeva Vault eTMF to keep TMFs audit ready at all times.
- As a member of the clinical systems and records team, work to provide consistency and training across all company-sponsored studies for a large international pharmaceutical company.
TMF Study Owner
Phlexglobal Ltd on Assignment to Pfizer
03.2016 - 07.2021
- The TMF Study Owner (SO) is the subject matter expert to and single point of contact for the Project Manager (PM) or equivalent and Study Team to ensure a complete and accurate TMF through documentation quality and consistency across clinical trials and programs.
- Accountable to the PM or equivalent for all global trial master file responsibilities conducted internally as well as externally at the Alliance Partners (APs) and Contract Research Organizations (CROs).
- Provide crucial TMF quality support to the Study Team as expected to establish a proactive quality-focused partner-relationship with the Study Team.
- Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes.
- Lead the set-up of the TMF Study Specific Document List (SSDL) and monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
- Ensure documentation flow is within projected timelines and determine course of actions to prevent and remediate delays/slippages.
- Ensure consistent use of standardized processes and technologies across clinical trials and programs.
- Serve as point of contact for internal and external audits of study TMF-related queries.
- Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
- Provide support and guidance to the Study Teams to drive performance against metric targets.
- Apply lessons learned to continuous improvement of documentation management practices across study teams.
- Provide education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
- Ensure that the program documentation supports the regulatory package requirements.
Clinical Trial Associate
ICON plc
01.2014 - 01.2015
- Support project managers and clinical teams of Phase IIIb extended and IV clinical trials.
- Organize and maintain clinical study documents; such as Main Study files, CRF files, and Monitoring files.
- Maintained eTMF and paper TMFs for numerous studies.
- Responsible for uploading documents into Sponsor based systems for eTMF and processing through the Sponsor workflow for document approval.
- Responsible for auditing eTMF and paper TMF for quality and inspection readiness.
- Responsible for collecting outstanding documentation for TMF from sites and CRAs.
- Assist in production of production of slides and power point documentation for project and departmental presentation.
- Assemble and ship study binders and other materials.
- Support personnel and study meetings.
- Assist in coordination of Site/Investigator payments.
- Coordinate ordering of study materials.
- Maintain contact with study sites for study needs/requirements.
Site Support Associate/Project Monitor
LabCorp Clinical Trials
01.2013 - 01.2014
- Manage and resolve problems with incoming lab samples for assigned studies.
- Accountable for daily functions associated with investigator site support.
- Contact and communicate to sites/CRAs/sponsors regarding queries, discrepancies or training.
- Ensure timely delivery of reports to Investigators/CRAs/sponsors.
- Oversee and coordinate with Kits and Logistics department to ensure proper delivery of supplies associated with sample receipt as region dictates.
- Interact with Specimen Management and laboratory staff to resolve problems.
- Review, call, and distribute abnormal results as designated by the Protocol.
- Interact with appropriate staff in order to manage daily pending/resulting of assigned clinical trial studies.
- Coordinate with Data Management to ensure that electronic data to be transmitted to customers is accurate, free of demographic errors and meets all requirements.
- Interact with project team members to resolve problems related to study setup, reporting or site compliance.
- Interact with partner lab to assist with internal functions.
- Utilize and maintain tracking tools and databases.
- Establish and maintain accurate files and records as required by the protocol.
Sr. Clinical Trial Associate
Quintiles
01.2006 - 01.2011
- Performance of in-house clinical monitoring activities.
- Maintain and manage data entry into clinical tracking systems in accordance with project requirements.
- Included tracking all visits, finding an over-payment error as well as a lack of contracts for visit extensions that were being conducted (company was able to save over $1 million).
- Worked with regulatory documents; including review and submission of Protocols, Investigator Brochures, ICFs, IRB documents, safety reports, and 1572 and supporting documentation.
- Maintained contact with Central IRB.
- Maintained contact with sites and CRA team to assure all documents were received and accurate for timely submission.
- Serve as a central contact for designated clinical and/or project communications/correspondence and associated documentation.
- Handled the process for distribution and collection of Data Clarification Forms (DCF's); including working with site staff to assure answers are accurate and all questions are appropriately answered.
- Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
- Assisted Clinical Team Leads with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Managed meeting minutes for US and global teams.
- Maintain central clinical files both electronic and paper files.
- Manage, supervise, and assist with quarterly file audits, on a large Phase III study with 3 protocols.
- Mentoring new clinical trial assistants and training them on project specific instructions.
- Responsible for on-boarding all new team members globally.
- Lead CTA and Global CTA assignments.
Retention Recruitment & Re-licensing Counselor
Devereux Foundation
01.2005 - 01.2006
- Responsible for re-licensing foster homes in assigned territory, according to state regulations.
- Maintain consistent contact with foster families and assure compliance with State of Florida Guidelines and Statutes.
- Liaison between foster parents and case management organizations.
- Responsible for preparing yearly re-licensing studies and interacting with Florida Department of Children and Families.
- Document reports and review referrals of abuse/neglect on all foster homes in the tri-county area.
- Communicate with legal liaison to assure reported foster homes are in compliance or seeking closure of the home.
- Work independently and meet interagency needs of the foster parent and resolve all conflicts and needs.
Case Manager
Polk Juvenile Correctional Facility
01.2002 - 01.2005
- Provided case management services for high risk juvenile delinquents.
- Maintained and audited the juvenile's case file during the duration of his stay.
- Participated in state audit activities.
- Volunteered to be on call 24/7 during state audits to assure files, facility, and facility procedures were audit ready.
- Provided training to newly hired staff and periodically to existing staff as a Red Cross certified HIV trainer.
- Mentored new case managers, floor staff, and unit managers when hired.
- During the majority of employment, handled more than one case load in an effort to maintain a high quality of service to each youth; this was done on a voluntary basis.
- Managed units housing especially high risk individuals; individuals with learning disabilities, developmental delays, severe drug use, sexually deviant behavior, violent behavior, and/or serious mental health issues.
- Often stayed after hours to assure stabilization of youths.
- Worked overtime hours to help manage youth in confinement.
- Managed unit for juveniles classified as dual diagnosis.
- Handled facility transfers for youth who were no longer progressing in the program.
- Often took over youth cases that were too problematic for other staff.
- Prepared monthly court documentation for the courts and juvenile probation officer.
- Coordinated youth exit procedures; scheduling a meeting with the probation officer, after care services, and parents.
- Provided family counseling services when needed and encouraged families to be involved in treatment.
- Organized and headed the youth's monthly treatment team sessions and documented these sessions for the file; including developing treatment plans goals, assuring adherence, devising consequences, and assuring all members of the treatment team were working toward the same goal.
- Developed/Wrote treatment plans according to youth's individual needs.
- Conducted daily group counseling sessions following state policy and guidelines, including holidays and weekends.
Child Protection Investigator (child abuse investigations)
Florida Department of Children and Families (DCF)
01.1999 - 01.2002
- Investigated claims of child abuse and neglect as a part of an investigative team.
- Interviewed all parties involved: parents, children, teachers, doctors, etc.
- Kept detailed and accurate notes on all activities.
- Worked with families to provide solutions to problems, including implementing rehabilitative services when appropriate and removal of children as a last option.
- Worked with community agencies to find counseling services, food banks, day care vouchers, TANF to provide monetary assistant when possible, and homes for families in desperate need.
- Participated in court hearing, testified in court, and prepared court documents.
- Prepared and maintained a case file documenting all activities.
- Working long hours as well as rotating weekend and holiday on call.
- Often assigned cases involving sexual abuse and teenage clients due to an ability to provide superior care to these delicate situations.
- Mentored staff on working with both sexual abuse victims and teenagers.
- Able to maintain positive rapport with families even through extremely difficult times based on an honest and straightforward approach.
Education
Bachelor of Arts - Criminal Justice
University of North Carolina At Wilmington
Wilmington, North Carolina, NC 08.1993 - 12.1998
Skills
Quality assessment
Documentation management
Team collaboration
Quality assurance
Proficient in Microsoft Suite
Timeline
Senior TMF Specialist
Chimerix, INC
07.2023 - 10.2025
Senior TMF Specialist
Arcus Biosciences, Inc
07.2022 - 06.2023
Sr. TMF Specialist
Daiichi Sankyo
07.2021 - 07.2022
TMF Study Owner
Phlexglobal Ltd on Assignment to Pfizer
03.2016 - 07.2021
Clinical Trial Associate
ICON plc
01.2014 - 01.2015
Site Support Associate/Project Monitor
LabCorp Clinical Trials
01.2013 - 01.2014
Sr. Clinical Trial Associate
Quintiles
01.2006 - 01.2011
Retention Recruitment & Re-licensing Counselor
Devereux Foundation
01.2005 - 01.2006
Case Manager
Polk Juvenile Correctional Facility
01.2002 - 01.2005
Child Protection Investigator (child abuse investigations)
Florida Department of Children and Families (DCF)
01.1999 - 01.2002
Bachelor of Arts - Criminal Justice
University of North Carolina At Wilmington
08.1993 - 12.1998