Teryl Nichole Nelson
Halifax
Summary
Dynamic Senior Clinical Trial Specialist with extensive experience at Jazz Pharmaceuticals, excelling in clinical trial management and regulatory compliance. Proven track record in optimizing trial processes and ensuring TMF audit readiness, while fostering effective communication and collaboration across teams. Adept at problem-solving and mentoring, driving successful study outcomes with a focus on quality assurance.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Specialist
Advanced Clinical embedded in Jazz Pharmaceuticals
Remote
04.2023 - 03.2025
- Supported the day-to-day operations related to study/site feasibility, start-up, maintenance, DBL, and close-out.
- Contributed to all aspects of TMF audit readiness, including, but not limited to, document filing, review, QC, running metrics, updating EDLs, authoring the TMF Plan, and authoring the TMF Index.
- Developed and implemented operational plans for clinical trial studies according to established protocol guidelines.
- Managed the study and site essential document review and collection from study start-up through the maintenance and close-out period.
- Provided timely completion of monthly study data review for the Clinical Operations team.
- Completed the CRO TMF oversight review to ensure fewer than 20% errors in the review.
- Completed CRO re-training of TMF review, if needed.
- Contributed to the development of trial-related plans and manuals.
- Organized study-related meetings, including but not limited to sending invites to team members, preparation of agenda/minutes, and maintenance of risk/action/decision logs.
- Led study-related meetings.
- Provided rapid action to address internal and site QA findings due to inspections or audits.
- Managed, coordinated, and oversaw activities with third-party vendors.
- Created trackers to maintain general study information, including study status, enrollment, queries, protocol deviations, and study-level documents and plans.
- Support the setup and management of clinical trial supplies and biosample management.
- Maintained effective communication between sponsors, investigators, research coordinators, clinicians and other members of the team throughout the duration of the trial.
- Oversaw study sites, including site performance, metrics, and monitoring report review.
- Provided oversight of the CRO to ensure tasks are completed in a timely and accurate manner.
- Supported the study lead in aligning study timelines across all functions.
- Drove CDA collection, feasibility questionnaires, and SQV with sites to ensure FPE for in-house clinical trial.
- Ensured compliance with Good Clinical Practice guidelines and all applicable regulations.
Site Management Administrator, Associate I, and Associate II
ICON
Remote
05.2021 - 03.2023
- Performed risk management, including site process evaluation and completion of Follow-Up Items, and escalated if necessary.
- Ensured timely and complete data entry and query management by sites.
- Acted as the primary contact for site management issues.
- Ensured TMF inspection readiness for blinded, unblinded, and open-label clinical trial teams.
- Performed reconciliation of site staff training.
- Completed semiannual TMF review.
- Set up and maintained site-related data in applicable clinical systems (e.g., CTMS, TMF, and applicable sponsor systems) according to project protocol, SOPs, and project plans.
- Performed all tasks in accordance with applicable guidelines (e.g., ICH-GCP), company and sponsor SOPs, project plans, study-specific processes, and local regulatory requirements.
- Completed peer interviews.
- Mentored peers.
- Completed site recruitment calls to ensure that sites were actively looking for study participants.
- Completed submissions to regulatory authorities.
- Attained ICF Second Review status.
- Taught in-person learning trainings to peers for eTMF use, TMF review, ICF review, and CTMS usage.
- Completed monthly site management calls (SMCs) with each site, which consisted of risk-based monitoring questions, SMC report creation and approval, data review, and assistance with query resolution.
- Served as an independent essential document reviewer.
- Provided team leadership.
Clinical Research Coordinator
Progressive Medical Research
Port Orange
09.2019 - 11.2020
- Reviewed the protocol and SOPs prior to working with patients.
- Quality-checked and edited essential documents.
- Performed patient-related aspects of subject visits.
- Recorded subject data in subject binders and electronic data capture applications.
- Assessed subject data for errors, and answered associated queries.
- Drew, aliquoted, and shipped blood specimens.
- Reviewed and edited protocols and budgets.
- Coordinated subject visits to ensure that out-of-window protocol deviations are avoided.
Education
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Wilmington, NC05.2020
Skills
- Clinical trial management
- Clinical operations
- Trial oversight
- Regulatory compliance
- Data management
- Study protocol development
- Trial Master File management
- Vendor management
- Project management
- Clinical data review
- GCP guidelines
- Clinical study reports
- Patient retention strategies
- Training and mentoring
- Meeting organization
- Site management
- Task prioritization
- Team collaboration
- Quality assurance
- Process optimization
- Problem solving
- Organizational skills
- Critical thinking
- Adaptability
- Multitasking Abilities
- Effective communication
- Vendor management and coordination
Certification
- Association of Clinical Research Professionals (ACRP)-Certified Professional, Jul2020
- National Institute on Drug Abuse (NIDA) Good Clinical Practice (GCP) Certification, Sep2020
Preferred Name
Nikki
Custom
- Veeva Vault eTMF, Subject Matter Expert
- Veeva Vault CTMS, Advanced
- Veeva Vault Quality, Advanced
- Veeva Vault JV-RIM, Advanced
- PhlexeTMF, Subject Matter Expert
- Siebel CTMS, Subject Matter Expert
- PSO CTMS, Advanced
- Medidata Rave EDC, Advanced
- Medidata Rave RTSM (Unblinded IRT), Advanced
- Almac IRT, Advanced
- Suvoda IRT, Advanced
- Endpoint IRT, Advanced
- Advarra IRB, Advanced
- WCG IRB, Advanced
- ICE, Advanced
- ECOA, Advanced
- Epicenter Portal, Advanced
- Labcorp Portal (Lablink), Advanced
- SmartSheets, Subject Matter Expert
- SharePoint, Subject Matter Expert
- BOX, Advanced
- Elluminate CDF, Intermediate
- Florence, Intermediate
- Workday, Advanced
- Microsoft Office (Word, Excel, PowerPoint, Outlook, and Teams), Subject Matter Expert
Accomplishments
- Received four awards for exceeding expectations at Jazz Pharmaceuticals.
Custom
References available upon request.
Timeline
Senior Clinical Trial Specialist
Advanced Clinical embedded in Jazz Pharmaceuticals
04.2023 - 03.2025
Site Management Administrator, Associate I, and Associate II
ICON
05.2021 - 03.2023
Clinical Research Coordinator
Progressive Medical Research
09.2019 - 11.2020
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
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