Clinical Research Operations Specialist

Nicole Burton Boykin

****************@*****.*** 910-***-**** Rose Hill, NC

SUMMARY

Seasoned Clinical Research Professional with 12 years of experience in operations and multi-site coordination. Skilled in IRB submissions, protocol development, CAPA Management and regulatory compliance. Seeking a Clinical Research Operations Specialist role to leverage expertise in trial management and site leadership.

WORK EXPERIENCE

CSL-Seqirus Wilmington, NC

Quality Specialist/Phlebotomist Sep 2024 – May 2025

•Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.

• Ensure the center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.

• Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.

•Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.

•Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.

•Assist Plasma center staff in completing other special projects or assignments, as requested.

Actalent (ICON-Accellacare Contract) Wilmington, NC

Regulatory Specialist/Clinical Research Coordinator Oct 2024 – Present

•Manage all regulatory submissions to IRBs, including initial submissions, continuing reviews, and amendments.

• Maintain and update DOA logs, protocol signature pages, training documentation, and site regulatory binders.

• Support multiple studies across Phase II–IV in therapeutic areas. Track and manage investigational product accountability and reconciliation.

•Communicate with monitors, sponsors, and labs to resolve protocol deviations and data queries. Prepare site for SIVs, IMVs, and close-out visits.

Meridian Clinical Research (Velocity Clinical Research) Remote

Site Development/Study Start-Up/Regulatory Specialist Jul 2022 – Aug 2024

•Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.

• Implement foundational protocols and procedures for new clinical trials, ensuring adherence to ICH/GCP/FDA guidelines and optimizing study design and management.

• Implement a risk management plan to identify, assess, and mitigate risks throughout the trial. The ICH E6(R2) Guideline introduces a risk-based approach to GCP.

•Regularly review and audit trial processes and documentation to ensure readiness for inspections. The FDA's Bioresearch Monitoring (BIMO) Program offers insights into what inspectors look for.

Dentrust Optimized Care Solutions Pipersville, PA

Event Manager/Phlebotomist/Medical Asst. Dec 2011 – Apr 2024

•Engage effectively with a multicultural clientele, ensuring clear communication across language and cultural barriers.

•Provide comprehensive information and support for Physical Health Assessments and Soldier Readiness Programs to military personnel.

•Consistently achieve 'exemplary' and 'exceed expectations' ratings in performance evaluations.

IQVIA (Avacare) Wilmington, NC

Clinical Research Coordinator/Phlebotomist/IV Therapy Aug 2021 - Jul 2022

•Conducted comprehensive data collection, coding, and analysis to support research objectives, ensuring effective collaboration with laboratory teams for the assessment of findings.

•Upheld stringent FDA regulatory compliance by meticulously maintaining detailed study records, including accurate drug dispensation logs.

•Contributed to participant recruitment strategies and fostered clear communication to ensure informed consent and address participant concerns throughout the study.

•Implement and monitor clinical trials to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines.

•Scheduled and led team study meetings; reported findings to Lead CRA.

•Maintained SOPs and Good Clinical Practice in compliance with ICH guidelines.

Trial Management Associates Wilmington, NC

Clinical Research Coordinator/Lab Assistant Apr 2020 - Jun 2021

•Managed the coordination and execution of clinical trials, ensuring participant compliance with study protocols and maintenance of ethical and regulatory standards.

•Conducted comprehensive data collection and analysis, while effectively collaborating with laboratory teams to interpret research findings.

•Facilitated participant engagement, contributed to recruitment initiatives, and meticulously maintained FDA compliant records of drug dispensation and study documentation.

•Screened and recruited subjects based on eligibility criteria for project participation.

•Collaborate with medical professionals to determine changes in subjects’ conditions.

Carolina Family and Urgent Care Lumberton, NC

Phlebotomist/Lab Tech/Iv Therapy Tech/Medical Technologist/CRC Oct 2019 - Apr 2020

•Analyzed unstructured data to discern meaningful patterns and insights, ensuring accurate diagnostic outcomes.

•Maintained rigorous sterilization and infection control standards, and administered IV nutrition and medications, contributing to optimal patient care and treatment efficacy.

LabCorp Wilmington, NC

Phlebotomist/Lab Technician/Float/Fingerprint Specialist Jun 2013 - May 2019

•Ensured stringent quality control measures for the legibility and clarity of fingerprint cards, facilitating accurate comparison processes.

•Communicated fingerprint analysis results effectively through comprehensive written reports and articulate oral briefings to law enforcement personnel.

•Provided expert training on fingerprinting techniques to staff across various medical facilities and hospitals, enhancing operational efficiency and knowledge sharing.

EDUCATION

Sampson Community College

Phlebotomy, EKG, Certified Nursing Assistant, & IV Therapy, Certificate in Technology

2010

to

2011

James Sprunt Community College

Certificate in Technology

2009

-

2023

University of Mount Olive

Business Administration/Healthcare

CERTIFICATIONS

2024

ACRP Member

SKILLS

2022

Site Development / Study Start-Up / Medidata RAVE / Phlebotomy / IV Therapy / Medical Technology/

Lab Techniques / CTMS / Pharmacovigilance / Data Management / Regulatory Submission / Safety Monitoring

/Leadership/SOP Development/Quality Assurance/Protocol Adherence/CAPA & Deviation Management/IRB Interactions/483 Investigations

Contact this candidate