Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic

Ciera Rankin

Raleigh,NC

Summary

Professional with over 7 years of expertise in Trial Master File (TMF) operations and clinical research project management. Demonstrated success in leading cross-functional teams, managing eTMF systems, and ensuring audit readiness while meeting tight deadlines. Skilled in eTMF system administration, user acceptance testing, and quality control, with a focus on continuous improvement and operational efficiency. Known for strong leadership and problem-solving abilities that enhance trial operations across sponsors, CROs, and vendors.

Overview

8
8
years of professional experience
1
1
Certification

Work History

TMF Specialist

Chimerix
Durham, NC
02.2024 - Current
  • Provided subject matter expertise for system setup, updates, and user access to ensure compliance with GCP and GDP standards.
  • Created guidelines and identified trends to improve eTMF completeness.
  • Conducted comprehensive TMF quality reviews and audits to maintain audit readiness.
  • Collaborated with study teams to ensure TMF completeness at core, country, and site levels.
  • Led eTMF migrations from CROs/vendors, organizing regulatory submission documentation.
  • Validated documentation for accuracy and compliance during migration processes.
  • Ensured consistent adherence to compliance standards throughout project lifecycle.
  • Facilitated interdepartmental communication to enhance TMF management practices.

Project Specialist/Associate

WCG
Durham, NC
02.2022 - 02.2024
  • Oversaw documentation management processes, ensuring inspection readiness through effective setup and tracking.
  • Conducted data quality control reviews, identifying trends and implementing corrective actions for data integrity.
  • Authored and maintained standard operating procedures and workflows to enhance operational efficiency.
  • Trained and mentored new hires, streamlining onboarding and fostering team collaboration.

TMF Lead II & Senior Project Specialist

Syneos Health
Morrisville, NC
01.2021 - 12.2021
  • Oversaw eTMF compliance and prepared documentation for audits to ensure readiness.
  • Configured Veeva Vault dashboards, enhancing reporting accuracy and visibility.
  • Managed TMF migrations and authored SOPs to streamline document handling processes.
  • Maintained detailed records of budgets, timelines, and deliverables across all projects.
  • Coordinated activities among teams, stakeholders, and vendors for timely project completion.
  • Implemented risk mitigation strategies to enhance overall project outcomes.
  • Led initiatives for communication between CRA and Project Leadership, aligning metrics with study timelines.
  • Delivered project-specific TMF training via teleconference, video conference, and in-person sessions.

Medical Laboratory Technologist

Actalent
Henderson, NC
09.2021 - 10.2021
  • On Assignment with Mako Medical.
  • Extracted DNA from respiratory samples for COVID-19 PCR testing.
  • Performed quality control assessments on DNA samples.
  • Conducted qPCR preparation and executed instrument runs.
  • Analyzed qPCR data to evaluate test results.
  • Monitored positive and negative controls to ensure quality standards.
  • Managed sample batches within LIMS, verifying resulting data.
  • Maintained inventory of reagents during regular shifts.
  • Collaborated with genomics supervisor regarding sample status and tasks.

Clinical Trial Associate

Clinipace
Morrisville, NC
10.2018 - 01.2020
  • Facilitated eTMF implementation and ensured document quality control for IRB submissions.
  • Achieved 95% compliance in maintaining regulatory documentation requirements.
  • Supported clinical study teams by tracking and reporting data accurately.
  • Developed trial master files according to GCP and ICH guidelines for regulatory adherence.
  • Managed clinical trial databases, ensuring precise data entry of source documents.
  • Executed reconciliations between source documents and database entries to confirm accuracy.
  • Strategically coordinated timely submissions and communications with site and study-level IRB/Ethics committees, including ICF preparations.
  • Oversaw investigator compliance through regular FDA debarment checks and licensing verification of study personnel.

Technologist Trainee

LabCorp
Burlington, NC
10.2017 - 07.2018
  • Conducted genomic analysis and DNA sequencing with 95% accuracy.
  • Managed laboratory operations, ensuring strict adherence to safety and quality standards.
  • Executed experiments under real-world conditions to gather essential performance data.
  • Performed preventive, predictive, and corrective maintenance to optimize machinery functionality.
  • Documented equipment testing and operations through systematic logging of system manuals.

Education

Bachelor of Science - Biological Sciences (Human Biology Concentration, Minor in Microbiology)

North Carolina State University
Raleigh, NC
07-2025

Skills

  • TMF oversight and management
  • ETMF administration
  • Audit support and inspection readiness
  • Quality assurance
  • Cross-functional collaboration
  • Metrics reporting and analysis
  • Training and mentoring
  • Leadership skills
  • Document control
  • Risk mitigation strategies
  • Study start-up and maintenance
  • Close-out processes
  • ETMF systems expertise
  • Data reporting tools

Certification

  • BIOWORKS Processing Technician Training
  • Veeva Site Vault Certification
  • Clinical.ly

Timeline

TMF Specialist

Chimerix
02.2024 - Current

Project Specialist/Associate

WCG
02.2022 - 02.2024

Medical Laboratory Technologist

Actalent
09.2021 - 10.2021

TMF Lead II & Senior Project Specialist

Syneos Health
01.2021 - 12.2021

Clinical Trial Associate

Clinipace
10.2018 - 01.2020

Technologist Trainee

LabCorp
10.2017 - 07.2018

Bachelor of Science - Biological Sciences (Human Biology Concentration, Minor in Microbiology)

North Carolina State University