Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

NEOKA WOFFORD

Dallas

Summary

Skilled clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes. Possess strong organizational skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures and enhancing data integrity in previous roles.

Overview

7
7
years of professional experience

Work History

Clinical Research Associate

IQVIA/Eli Lilly
05.2022 - Current
  • Identify and select appropriate research sites, ensuring they meet the necessary criteria for the study.
  • Conducting regular site visits to assess protocol adherence, data accuracy, and compliance with Good Clinical Practice (GCP) guidelines.
  • Reviewing and verifying data collected at the site, ensuring accuracy and completeness.
  • Providing training to research staff on study protocols, procedures, and data collection methods.
  • Overseeing the overall management of the study site, including recruitment, enrollment, and retention of participants.
  • Ensuring all study activities are completed, data is finalized, and the study is properly closed out.
  • Ensuring accurate and complete data collection according to the study protocol.
  • Addressing data queries and discrepancies in a timely manner.
  • Reviewing data for accuracy and completeness, identifying potential issues, or errors.
  • Developing and implementing data handling guidelines to ensure data validity.
  • Ensuring that all study activities are conducted in accordance with the study protocol and relevant regulations.
  • Adhering to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.
  • Assisting with the preparation and submission of regulatory documents.
  • Maintaining communication with the ERB, and ensuring compliance with ethical guidelines.
  • Acting as a liaison between the sponsor and the research site, facilitating communication and collaboration.
  • Preparing and submitting reports on study progress, site activities, and data findings.
  • Working collaboratively with other members of the study team, including investigators, nurses, and other research staff.
  • Participated in internal audits related to clinical research operations processes.
  • Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
  • Performed clinical research activities including protocol development, subject recruitment and data collection.
  • Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
  • Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
  • Monitored safety events reported during the course of clinical trials in accordance with SOPs.
  • Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
  • Ensured timely completion of all deliverables by tracking project timelines and milestones.
  • Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
  • Spearheaded qualification, initiation, monitoring and close out visits by coordinating with project management team.
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Checked electronic data capturing systems for integrity and compliance.

Clinical Research Coordinator

Neurology Consultants of Dallas
Dallas
11.2020 - 05.2022
  • Lead Coordinator of several sponsored clinical trials, phase I, phase II and phase IV.
  • Strong knowledge of Federal Regulations, Good Clinical Practices (GCP)
  • Consented/Filed and stored informed consents in EMR
  • Well versed in Regulatory filing
  • Query Resolution
  • Data Analytics-ability to use several Data Programs such as: Inform, Veeva Vault, Firecrest, DrugDev, IWRS and several more
  • Overseeing PI (Principal Investigator) oversight
  • Experienced in conducting EEG and ECG/EKG procedures
  • Ability to multitask without compromise to quality
  • Exceptional communication with cohorts, Sub-I, PI, and Subjects/Study partners
  • Intense detail to my work including labs, data input, and communication with sponsors
  • Coordinated investigator meetings, conference calls, and site initiation visits as needed.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
  • Prepared informed consent forms for review by ethics committees.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Assisted in preparing periodic reports summarizing progress of clinical studies.
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Collected, processed and delivered specimens from trial participants.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Took vital signs and collected medical histories as part of study protocols.
  • Placed orders for medications to be used in studies.

Lead Clinical Research Coordinator

Children's Healthcare of Atlanta/Pediatric Hem/Onc
Atlanta
10.2018 - 08.2020
  • Managed drug supply inventory for multiple trials.
  • Tracked adverse events reports from participating sites throughout the course of each trial.
  • Developed and maintained clinical trial documents, such as protocols, case report forms, and informed consent forms.
  • Organized and conducted investigator meetings to ensure protocol compliance.
  • Researched literature pertaining to specific therapeutic areas as needed.
  • Monitored laboratory results to ensure quality control of data collected.
  • Participated in internal audits of clinical studies when required by sponsors or regulatory agencies.
  • Performed ongoing monitoring visits at participating sites according to established schedules.
  • Generated timely responses to queries from sites regarding protocol-related information.
  • Ensured appropriate documentation was completed by investigators in accordance with ICH and GCP guidelines.
  • Provided support in preparation for FDA inspections including review of relevant documents.
  • Kept patient care protocols and clinical trial operations in compliance.
  • Collected, processed and delivered specimens from trial participants.
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Gathered and reviewed study data.
  • Took vital signs and collected medical histories as part of study protocols.

Education

Master of Science - Biology

Georgia State University
Atlanta, GA
01.2015

Bachelor of Science - STEM

Spelman College
Atlanta, GA
05-2010

Skills

  • Clinical trial management
  • Data analysis
  • Regulatory compliance
  • GCP adherence
  • Protocol development
  • Site monitoring
  • Data verification
  • Communication skills
  • Problem solving
  • Attention to detail
  • Time management
  • Team collaboration
  • Patient recruitment strategies
  • Clinical study reports
  • Action planning
  • Monitoring visits
  • Informed consent process
  • IRB submissions
  • Interdepartmental collaboration
  • ICH guidelines
  • Accountability
  • Dispensing oversight
  • Study protocols
  • Research sops understanding

Languages

English, Native

Timeline

Clinical Research Associate

IQVIA/Eli Lilly
05.2022 - Current

Clinical Research Coordinator

Neurology Consultants of Dallas
11.2020 - 05.2022

Lead Clinical Research Coordinator

Children's Healthcare of Atlanta/Pediatric Hem/Onc
10.2018 - 08.2020

Master of Science - Biology

Georgia State University

Bachelor of Science - STEM

Spelman College

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