Nicholas Moore
Port St. Joe,FL
Summary
Dedicated professional prepared to bring extensive expertise and results-oriented approach to clinical trial operations. Known for effectively managing tasks and supporting organizational goals through collaborative efforts and adaptive strategies. Recognized for excellent communication and analytical skills, ensuring seamless operations and consistent outcomes.
Overview
10
10
years of professional experience
Work History
Clinical Study Specialist, Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
04.2022 - 07.2025
- Assigned to Rare Disease, Hematology, and Ophthalmology trials.
- Organizes and delivers analyzable reports and metrics to the clinical study lead
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
- Collates data for assessments such as feasibility and site selection and reviews site usability database
- Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
- Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
- Collates materials for training and investigator meetings
- Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
- Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
- Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
- Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
- Manages and maintains team SharePoint and/or shared drive sites, as needed
- Communication with sites as directed and maintains site contact information
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- May manage or contribute to oversight of Third Party Vendors (TPV)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
- Proactively recommends process improvement initiatives for the department
- Developed and implemented process improvements to enhance operational efficiency.
- Mentored junior staff, fostering professional development and skill enhancement.
- Collaborated with stakeholders to align project objectives with business strategies.
- Followed all company policies and procedures to deliver quality work.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Maintained database systems to track and analyze operational data.
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
Contract - Clinical Study Specialist, Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
08.2020 - 04.2022
- Assigned to COVID, Rare Disease, and Hematology trials.
- Organizes and delivers analyzable reports and metrics to the clinical study lead
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
- Collates data for assessments such as feasibility and site selection and reviews site usability database
- Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
- Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
- Collates materials for training and investigator meetings
- Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
- Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
- Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
- Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
- Manages and maintains team SharePoint and/or shared drive sites, as needed
- Communication with sites as directed and maintains site contact information
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- May manage or contribute to oversight of Third Party Vendors (TPV)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
- Proactively recommends process improvement initiatives for the department
- Developed and implemented process improvements to enhance operational efficiency.
- Mentored junior staff, fostering professional development and skill enhancement.
- Collaborated with stakeholders to align project objectives with business strategies.
- Followed all company policies and procedures to deliver quality work.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Maintained database systems to track and analyze operational data.
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
In-House Clinical Research Associate, Clinical Trial Management
ICON Clinical Research
02.2020 - 08.2020
- Assigned to Women’s Health trials.
- Provide support to sites and CRAs directly to process and resolve queries and requests as needed.
- Serve as primary in-house contact for sites and investigators participating in studies.
- Become familiar with the principles of and assist with investigator recruitment.
- Conduct and complete remote site management activities, with support as needed, according to applicable SOPs and the Study Monitoring Plan.
- Contact clinical sites for specific requests, including enrollment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action item resolution or other sponsor specific tasks.
Clinical Trial Assistant, Clinical Trial Management
ICON Clinical Research
09.2017 - 02.2020
- Assigned to CNS & Oncology trials.
- Support the CTMs, Project Managers, and CRAs on a daily basis to ensure the most effected and efficient conduct of clinical studies.
- Process study team and site personnel access updates for the CTMS and vendor systems. Participate in study meetings (Cross functional, internal, QRRM, & CRA call) and complete meeting minutes.
- Log, file, and reconcile study team and site staff study specific training. Monitor queries and follow-up with sites for resolution. Correspond with site staff to solve study issues.
- Oversee and maintain (including QC) study files in eTMF. Reconcile monitoring visit trip reports. Generate follow-up and confirmation letters for CRAs.
- Process and track investigator site level payments. Distribute and file SOPs and other mass communications.
- Track acknowledgements of receipt, SSU contracts, and budget negotiations. Construct data review and query reports.
- Compile and distribute study binders and other study materials to sites.
- Collect, submit, and follow-up for regulatory documents (such as FDF and 1572).
- Create QRRM call PowerPoint slides. Create Excel graphs using PivotTables. Create study Newsletters using MS Publisher.
- Mentor new hire CTA and study team members. Perform ad hoc duties as assigned.
Emergency Department Scribe
ScribeAmerica, LLC.
05.2015 - 07.2017
- Accompany the healthcare provider into patient examination rooms in order to transcribe the patient's history, physical exam findings, consultations, labs, X-rays, and other evaluations, as stated by the provider, directly into the medical record
- Maintain a comprehensive list of active patients to assist the provider remain organized and efficient for the roughly 15-25 patients seen per shift
- Prepare plans for follow-up care, as directed by the provider
- Process admission and discharge paperwork
Education
Bachelor of Science - Biochemistry and Molecular Biology
The University of Tennessee
Knoxville, TN05.2016
Skills
- Expert problem solving
- Analytical thinking
- Documentation management
- Adaptability and flexibility
- Project management
- Logistics coordination
- Teamwork and collaboration
- Operational enhancement
- Vendor relations
- Compliance monitoring
- Proficient in Word, Excel, Outlook, PowerPoint, OneNote, Teams, Publisher, Medidata RAVE electronic data capture, Perceptive IRT, YPrime IRT, CRF/Signant Health TrialManager, APECs, Firecrest, Box, eRoom, ICOTrial, ICONIK, Firecrest, Planview, Bioclinica, iLearn, VeevaVault/TRACK eTMF (ICON & REGN Super User), MySignatureBook, Adobe Sign, Connexus IRB, WCG Feasibility, SharePoint, REGN ODR, Adobe Acrobat, Concur travel/expense management, Oracle time/absence management
Languages
English
Native or Bilingual
Timeline
Clinical Study Specialist, Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
04.2022 - 07.2025
Contract - Clinical Study Specialist, Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
08.2020 - 04.2022
In-House Clinical Research Associate, Clinical Trial Management
ICON Clinical Research
02.2020 - 08.2020
Clinical Trial Assistant, Clinical Trial Management
ICON Clinical Research
09.2017 - 02.2020
Emergency Department Scribe
ScribeAmerica, LLC.
05.2015 - 07.2017
Bachelor of Science - Biochemistry and Molecular Biology
The University of Tennessee
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