Megan Abbott
Summary
Seasoned Regulatory Affairs Officer with 13 years in developing effective processes and executing regulatory affairs initiatives for the Clinical Research industry. Improved processes and assisted product development in meeting regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
12
12
years of professional experience
Work History
Senior Regulatory Operations Specialist
Lotus Clinical Research
04.2020 - 02.2023
- Completed all IRB and other regulatory submissions for the company
- Completed reviews of essential documents following Essential Document Checklist QC and IP Release Checklist QC.
- Collected, received, and performed first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implements corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable)
- Coordinated the review of all IND reports by Investigators for IRB submission.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Wrote or updated standard operating procedures, work instructions or policies.
- Performed and lead monthly QCs of the eTMF always maintains an audit ready status.
- Ensured that TMF Monthly Metrics reviewed were always above 85%.
- Coordinated review of all IND reports by Investigators for IRB submission
- Monitored and maintains protocol and ICF version control
- Participated in project specific training as required
- Created training processes in accordance with relevant Standard Operating Procedures and Work Instructions
- Participated in leading team meetings and updated SOPS and WIs that were to be implemented
- Ensured study start up activities wet met per sponsors timelines
- Managed and maintained hospital accreditations for all staff at all Lotus locations
- Oversaw site certifications (CLIA, DEA, etc.)
- Implemented regulatory guidance procedures.
- Recommended improvements to processes.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Motivated and trained employees to maximize team productivity.
- Tracked and analyzed reports to determine needed improvements.
- Worked with Project Managers and functional leads to ensure that the Essential Document List in the eTMF is an accurate reflection of required documents per study.
- Prepared and maintained the Trial Master File (TMF) for all studies being managed by the company.
Senior Site Activation Specialist
Worldwide Clinical Research
09.2019 - 04.2020
- Supported the collection of country and site level intelligence, as per Worldwide internal procedure
- Performed pre-award feasibility studies for potential sites as requested
- Supported the development of a preliminary potential site list
- Supported Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires
- Supported the development and adaptation of country/site specific informed consent forms
- Maintained regular communication with sites to ensure timely completion of start-up and maintenance activities
- Where applicable, provided local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project
- Where required, completed, managed and/or supported country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.)
- Conducted training of other SASs as requested and appropriate.
- Support of translations as per Worldwide internal SOP of essential document collection and review to facilitate synchronized start-up.
- Collected, received, and performed first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implements corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable)
- Tracked study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the Project Manager or other functional leads.
- Conducted training of other SASs as requested and appropriate.
Senior Project Team Associate
PharPoint Research, LLC
03.2019 - 04.2020
- Functioned in the role of Super User for the Clinical Trial
- Management System CTMS (Clinical Force) for the company
- Responsibilities include the development of training modules to be implemented on Litmus Training
- Management System, da ta input into respective modules, study template development, permission and role management, project tracking, provided assistance and training to other team members utilizing the system and interfacing with the accounting group as necessary for the investigator payment module
- Created and implemented process documents for the clinical department
- Assisted with the assessment of current and future clinical management software
- Developed and implemented departmental working practices in support of clinical study organization
- Trained new employees hired in the role of Project Team
- Associates as well as other clinical operations staff
- Assisted the Project Manager or designee with the development of vendor specifications per study protocol, collection of cost estimates and assists with the implementation of study vendors as necessary
- Participated in the execution of multiple clinical studies and assumes necessary responsibilities as delegated by the project management staff, including the preparation of research documents, monitoring guidelines and study management plans.
Senior Country Submissions Specialist
Syneos Health
10.2015 - 02.2019
- Tracked all company and essential study documents required for the implementation, monitoring and evaluation of clinical trials
- Assisted with the identification and recruiting of investigator physicians and study sites through the contact module within the CTMS system
- Tracked and assisted with distribution as well as the review process of all study contracted services, such as central lab,
- IVRS, central IRB, IP vendors, meeting planning services, core cardiac laboratories, Phase I units, etc
- Developed and maintains the project study files according to company SOPs
- Developed tracking reports for study progress within the
- CTMS system
- Interacted directly with sites to collect, review and process study start up essential documents
- Assisted Quality Assurance by performing quality control audit procedures, including PharPoint Research and
- Investigator study files, and clinical review of collected data and clinical forms
- Updated all sponsor communications within the trial master file as directed by the project manager
- Submitted timely and accurate project status reports as required by the Sponsor and per WIs and SOPS
- Responded in a timely manner to expedient resolution of questions associated with the tracking of the clinical study within the CTMS system
- Responded to project team members in a professional, timely and thorough manner using company resources as necessary
- Maintained compliance with all policies, procedures of the company, including security and safety
- Routinely stays abreast of GCP, updated guidance from FDA as it relates to clinical research
- (formerly inVentiv Health Clinical)
- Conducted research and maintained proficiency of local requirements for documentation of IRB/EC and
- Completed Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory
- Intelligence portal
- Liaison with study sites regarding essential document collection and assisting with IRB/EC submissions
- Mentored junior staff on local regulations and internal procedures.
Site Regulatory Specialist
INC Research, LLC
02.2014 - 10.2015
- Occasionally played the role of Country Expert for internal intelligence collection and training purposes
- Lead a single country/domestic study by providing work direction and oversight to teams
- Completed review of essential documents following Essential Document Checklist QC
- Ensured all relevant documents are submitted to the Trial
- Master File (TMF) as per company SOP/Sponsor requirements
- Supported other departments as necessary
- Acted as study start-up project lead on projects with limited scope establishing the CTA submission strategy (Regulatory
- Authorities and IRB/EC)
- Acted as Subject Matter Expert (SME) for a specific function of EDCS in a specific project or region
- Provided regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status and maintain project tracking systems for assigned projects
- Customized country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents
- Completed assigned training programs and applying learning
- Completed necessary administrative tasks
- Performed other duties as assigned
- Collected and reviewed essential document packages for site activation
- Provided regular local status updates to SSU Project Lead, update appropriate study-tracking tools with local essential document and ethics committee status, when required
- Prepared and submitted Central EC Applications, Local EC applications, RA applications and other local regulatory authorities and hospital approval submissions as required
- Worked with contracts lead to agree on site-specific country template contract and budget
- Followed the project direction and expertise provided by the designated country SSUL
- Served as the primary point of contact for the SSUL/PM (or designee during start-up on a few allocated projects
- Forecasted submission/approval timelines and ensured they were compiled; if forecasted timelines were not reached: provided clear rationale for delays, contingency plan to mitigate impact, and escalated the issue as soon as identified
- Monitored basic financial aspects of the project and the number of hours/tasks available per contract; escalated discrepancies in a timely fashion.
Global Vendor Contracts Specialist
INC Research, LLC
03.2013 - 09.2013
- Reviewed Standard Operating Procedures (SOPs) and Work
- Instructions (WI) in a timely manner and kept training records updated accordingly
- Ensured continuous improvement of quality in all Site
- Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competnt Authorities and ECs, etc.)
- Assisted with administration of customer, vendor and site contracts
- Developed and bring to closure contracts with vendors who provide necessary goods and services
- Maintained primary responsibility for the boilerplate provisions contained within approved contract templates
- Facilitated contract management functions with internal and external legal, finance and clinical operations
- Liaison between Contracts & Functional Services staff and internal/external customers
- Provided functional guidance and keeps Contracts &
- Functional Services teams aware of contract status
- Communicated and explained legal and budgetary issues to internal and external parties
- Assisted in generating amended documents
- Prepared contract management documentation for projects
- Maintained contract templates and study specific files and databases
- Maintained strong working relationships with internal project teams
- Streamlined contracts/proposals into internal processes
- Initiated and introduced creative ideas and solutions
- Reviewed non-standard contract documents provided by a vendor
- It is the responsibility of this position to evaluate the offered external contract document against INC Research,
- LLC guidance and policy
- Maintained open communication with the requesting stakeholders and operational teams
- Provide support as needed and act to ensure that the contract document as executed by INC Research, LLC fairly and faithfully reflects the scope, budget and operational matters as approved by the relevant stakeholder(s)
- Attended to administrative matters related to the approval and execution of contracts including securing Nondisclosure
Regulatory Records Specialist
INC Research, LLC
06.2011 - 03.2013
- Agreements, Certificate Insurance or other financial documentation as required., Created, maintained, and tracked the document repository for all study-related clinical documents in accordance with relevant guidelines to ensure compliance and security
- Processed, scanned, indexed, routed, and maintained files for clinical documents according to SOPs/WIs
- Participated in preparation and reconciliation of Trial Master
- File documentation related to archival and shipments to sponsors
- Adhered to sponsor-specific tracking guidelines as well as relevant SOPs/WIs
- Participated in project specific training as required
- Created training processes in accordance with relevant
- Standard Operating Procedures and Work Instructions
- Participated in leading team meetings
- Mentored staff in process changes of handling the essential regulatory documents
- Page 7 of 7
Education
GCP Certificate -
CITI
04.2023
Bachelor of Arts - International Business, Anthropology
Peace College
2011
Skills
- Regulatory Monitoring
- Knowledge of ICH GCP
- Project Development
- Time Management
- Compliance Oversight
- Regulatory Documents
- Regulatory Compliance
- Clinical Trial Protocols
- US/CAN Regulatory Compliance
- System Improvements
- Risk Management
- Document Review
- Training
- ISO Standards
- Critical Thinking
- Federal Regulations
- Pre-Market Submissions
- Regulatory Processes
Timeline
Senior Regulatory Operations Specialist
Lotus Clinical Research
04.2020 - 02.2023
Senior Site Activation Specialist
Worldwide Clinical Research
09.2019 - 04.2020
Senior Project Team Associate
PharPoint Research, LLC
03.2019 - 04.2020
Senior Country Submissions Specialist
Syneos Health
10.2015 - 02.2019
Site Regulatory Specialist
INC Research, LLC
02.2014 - 10.2015
Global Vendor Contracts Specialist
INC Research, LLC
03.2013 - 09.2013
Regulatory Records Specialist
INC Research, LLC
06.2011 - 03.2013
GCP Certificate -
CITI
Bachelor of Arts - International Business, Anthropology
Peace College
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