Summary
Overview
Work History
Education
Skills
Timeline
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Katelyn Medley

Pace,FL

Summary

Knowledgeable, efficient, and forward-thinking healthcare professional with a passion for CRO and Clinical Trial Management. Well-versed in coordinating and managing projects in oncology as well as many other therapeutic areas. Always willing to adapt and take on any task to support my team and help business succeed. Offer strong management and leadership skills and ability to foster and maintain client relationships. Seeking opportunity in demanding, deadline-driven environment.

Overview

5
5
years of professional experience

Work History

Sr. Clinical Project Coordinator

IQVIA Biotech
Durham, NC
08.2021 - Current
  • Track, measure, and evaluate project metrics
  • Work in conjunction with Project Manager to maintain project timelines, formulate study documents, and develop required materials per study scope
  • Maintain trial master files to ensure they are current, complete, and audit ready
  • Develop project specific procedural documents, assist in changes in scope of work, and provide vendor oversight
  • Maintain support responsibility, including scheduling, managing agenda updates, and meeting minutes for project team meetings
  • Provide administrative support including mass site communication, shipping, filing, tracking and status summarization
  • Initiate or oversee the purchase order process, code project specific invoices and submit for approval, and monitor the purchase order balance to ensure sufficient funds
  • Per project requirements, manage protocol deviation tracking, including client evaluation and subsequent documentation
  • Train and mentor more junior project support staff.

Associate Project Manager Training Series

IQVIA Biotech
Durham, NC
03.2023 - 05.2023
  • Completion of IQVIA Biotech sponsored Project Coordination Development Program (Associate Project Manager training track) with 38 hours of completed training covering topics of Scope Management, Financial Management, Timeline Management, Risk Management, Vendor Management, Quality Management, and Communications Management
  • Completion of IQVIA Biotech sponsored Associate Project Management Training Series
  • This 12-week training series covered the following topics: Project Management & The Role of the APM, Functional Overviews, Project Life-cycle, Customer Relationship Management, Project Planning, Scope and Financial Management, Vendor Management, Analytics & Reporting, TMF, Quality, Study Specific Training, Change Control & Communications.

Associate Operations Specialist

IQVIA
Durham, NC
03.2021 - 08.2021
  • Processed safety data from various sources according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements
  • Performed pharmacovigilance activities
  • Managed adverse Events (AE)/endpoint information
  • Managed database entry including coding AE, products, medical history, and labs, writing narratives, and other project activities as per internal/project timelines
  • Assessed lifecycle safety data for reportability and reported to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation
  • Met all quality standards per project requirements, identified quality problems, and brought them to the attention of a senior team member
  • Collaborated with cross-functional teams to achieve company objectives
  • Mentored new team members, if assigned by the manager, and performed all other duties as assigned.

Clinical Research Coordinator

ALLIANCE FOR MULTISPECIALTY RESEARCH LLC
Mobile, AL
06.2019 - 02.2021
  • Worked alongside study primary investigator while maintaining GCP guidelines, ALCOA standards and following site’s SOPs
  • Obtained informed consent, medical history, concomitant medications, studied inclusion and exclusion, recorded adverse events, and input visit data into EDC
  • Conducted full range of patient and protocol assessments, including safety and efficacy, vital signs and EKG results
  • Dispensed investigational product and educated patients on drug compliance and how to use a paper/electronic diary to comply with study protocol
  • Q/A of charts after each subject visits, query resolution, prepared charts and regulatory documents for monitoring visits and worked closely with CRA during on-site/remote monitoring visits
  • Prepared and organized clinic and charts prior to subject visits, maintained up to date records in Clinical Conductor and completed all necessary study specific trainings
  • Experienced in multispecialty study areas, including diabetes, migraines, osteoarthritis of the knee and shoulder, adhesive capsulitis of the shoulder, Covid-19, Anthrax and Ebola vaccines.

Education

Bachelor of Science - Professional Health Sciences

University of South Alabama
12.2018

Skills

  • Microsoft Office
  • Multiple EDC, IVRS and eTMF platforms
  • GCP Knowledge
  • Clinical Trial Management
  • Budget Management
  • Team Leadership
  • Conflict Resolution
  • Project Planning
  • Cross-functional Collaboration
  • Training and Mentoring
  • Process Improvement
  • Relationship Building

Timeline

Associate Project Manager Training Series

IQVIA Biotech
03.2023 - 05.2023

Sr. Clinical Project Coordinator

IQVIA Biotech
08.2021 - Current

Associate Operations Specialist

IQVIA
03.2021 - 08.2021

Clinical Research Coordinator

ALLIANCE FOR MULTISPECIALTY RESEARCH LLC
06.2019 - 02.2021

Bachelor of Science - Professional Health Sciences

University of South Alabama

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Katelyn Medley