Summary
Overview
Work History
Education
Skills
Websites
Legal Experience
Timeline
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Alannah Felix

Shawnee,KS

Summary

Highly motivated Juris Doctor graduate with multidisciplinary experiences in Clinical Trial Start-Up, Regulatory and Compliance standards, Clinical Trial Contracts; and extensive knowledge in Family Law. Strong communication and negotiation skills, with a working knowledge of legal terminology, general law, legal proceedings, and general Clinical Trial Contract Law. Possesses a solid foundation in Clinical Trial regulatory and compliance principles. Ability to cultivate positive professional relationships with clients and colleagues. Successful at thriving in high-stress, high-pressure environments, and situations. Proven ability to manage multiple projects and meet tight deadlines in a fast-paced environment. Customer-focused individual with a passion for delivering exceptional service. Strong interpersonal skills with a talent for effectively addressing concerns. Committed to improving customer satisfaction and driving positive outcomes. Proactive and versatile professional with a dedication to quickly adapting to new challenges. Strong problem-solving abilities and a proven track record of fostering strong relationships with clients and team members. Focused on supporting team success and achieving positive results.

Overview

14
14
years of professional experience

Work History

Clinical Trials Associate 2

IQVIA
Overland Park, KS
01.2022 - 01.2024
  • Operated as the main regulatory point of contact throughout the duration of a clinical trial, ensuring high quality communication and correspondence between IQVIA/Single Sponsor (Amgen) and the selected Site(s)
  • Collaborated with Clinical Team Leads (CTLs), Clinical Research Associates (CRAs), and other Clinical Trial Associates (CTAs), on preparing and maintaining regulatory clinical trial documentation for all phases of clinical trials; Study Start-Up, Feasibility, Maintenance, and Close-Out, on numerous clinical trials simultaneously
  • Submitted and maintained all relevant clinical trial documents to the electronic Trial Master File (eTMF)
  • Accurately updated and maintained clinical systems, such as, eClinical to track site(s) compliance and performance within multiple Trials/Project timelines simultaneously
  • Worked closely with the CTLs, Contract and Budget Team Members, and all other Trial Team Members necessary to accurately review and approve all required regulatory documentation prior to submitting to the appropriate regulatory agencies, such as the Institutional Review Board (IRB)
  • Conducted an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance per sponsor SOP, including editing new and revised consent forms to ensure regulatory compliance and alignment with sponsor and IQVIA document standards
  • Served as the Lead CTA on a high priority study
  • Responsibilities included; updating and maintaining study notebooks, sending study communication to all study sites, reviewing country level ICFs and protocol amendments, working and communicating closely with the study CTLs, submitting all required regulatory documents to the appropriate regulatory agencies for approval, and many more

Research Contracts Specialist

University of Kansas Medical Center Research Institute Research Contracts Office (KUMCRI)
Fairway, KS
01.2019 - 01.2021
  • Reviewed Clinical Trial Agreements for required contractual language established by KUMCRI and the University’s Office of General Counsel prior to Clinical Trial start-up, and/or for ongoing Clinical Trials primarily for the Cancer Center
  • Negotiated with Trial Sponsors (Sponsors) and Clinical Research Organizations (CROs) to revise contract wording to meet the established standards of KUMCRI
  • Operated as the liaison on behalf of KUMCRI throughout the negotiation process to ensure high quality communication while collaborating on multiple fast paced project timelines simultaneously
  • Attended weekly contract budget meetings and calls to discuss the status of the and provide feedback on completion timelines
  • Conducted an accurate review of Informed Consent Forms, to ensure language compliance with applicable FDA regulations, ICH GCP guidance, and operational compliance per KUMCRI
  • Maintained accurate records of the status of clinical trial agreements (CTAs), Master CTAs, amendments, ICFs, etc., within the internal data collection systems
  • Communicated with various departments (Regulatory, Budget, Investigational Pharmacy, Office of General Counsel, etc.), throughout the process of the negotiations
  • Reviewed and negotiated various other contracts including, Patient Informed Consent Forms, Amendments, Delegation of Authority, Letter of Indemnification, Master Clinical Trial Agreements, Confidential Disclosure Agreements, etc
  • Assisted with training new contract personnel on all required contractual language and general SOPs

Knowledge & Process Management Specialist

H&R Block Corporate
Kansas City, MO
01.2018 - 01.2019
  • Conducted research and analyzed internal data to improve quality of service to retail service clients
  • Compiled data based on internal processes to present to upper leadership to improve clients’ experiences
  • Reviewed current internal processes used by call center client service specialists and collaborated with other team members to note any areas that required updates or noted areas for potential improvement in the processes

Client Service Representative-1

H&R Block Corporate
Kansas City, MO
01.2018 - 12.2018
  • Assisted and effectively help resolve H&R Block Clients with escalated customer service tax return preparation issues, requests, or concerns
  • Worked directly with the Store Managers and Regional Managers to assist in resolving the client’s concerns

Judicial Law Clerk to the Honorable Bryan E. Round

Jackson County Sixteenth Circuit Court
Kansas City, MO
01.2016 - 01.2017
  • Drafted all Orders and Judgments entered by the Court; specializing in Domestic Law
  • Reviewed Motions, Pleadings, Orders, Judgments, etc
  • Submitted before the Court
  • Communicated and collaborated closely with the Judge on all cases set on the Courts docket
  • Provided day to day support as requested by the Judge
  • Scheduled all Court dates/proceedings to be held before the Court at the Judge’s request on Missouri Case Net
  • Conducted legal research; including Statutes, relevant Case Law, etc
  • For the Court on all Cases being presented before the Court and for review before final Orders and Judgments were entered by the Court
  • Communicated with Attorneys and Pro Se Litigants on behalf of the Court (scheduling, court rules, providing orders, etc.)
  • Submitted all required Court documents to the Court filing system and maintained an accurate record of all Court proceedings and records
  • Attended and took detailed case notes on behalf of the Court during all Domestic and Civil Court Proceedings

Shift Manager

Beauty Brands Salon & Spa
Lawrence, KS
07.2011 - 07.2013
  • Identified needs of customers promptly and efficiently.
  • Scheduled clients for Salon and Spa appointments by telephone.
  • Resolved conflicts between staff members in a professional manner.
  • Assigned tasks to employees and monitored productivity, performance and task completion.
  • Supervised overall functioning of salon, spa, and retail areas.
  • Performed money counting tasks in drawers, ensuring accurate bank deposit handling.
  • Maintained updated product knowledge through continuing education and advanced training.
  • Recognized by management for providing exceptional customer service.
  • Resolved conflicts between employees or customers in a professional manner.
  • Ensured completion of all opening and closing duties were completed accurately according to established guidelines.

Customer Service Specialist

Beauty Brands Salon & Spa
Lawrence , KS
06.2010 - 07.2011
  • Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
  • De-escalated problematic customer concerns, maintaining calm, friendly demeanor.
  • Addressed customer questions and concerns regarding products and services.
  • Processed returns, refunds, exchanges according to company policies and procedures.
  • Developed strong customer relationships to encourage repeat business.
  • Managed overall cleanliness of store.
  • Recognized by management for providing exceptional customer service.

Education

Bachelor of Arts - Psychology

The University of Kansas
Lawrence, KS
01.2013

Skills

  • Critical Thinking
  • Time Management
  • Communication Skills
  • Attention to detail
  • Organizational Skills
  • Leadership
  • Adaptability
  • Project Management
  • Legal Research
  • Contract Negotiation
  • Case Management
  • Legal Document Drafting
  • Professionalism and Ethics
  • Trial Preparation/Discovery
  • Legal Document Filing
  • Clinical Trial Management
  • Clinical Trials Contracts
  • Clinical Trial Protocols
  • Customer Service
  • Client Management
  • Database Management
  • ETMF
  • EClinical
  • Regulatory Agencies; Advarra, WCG, ICH, FDA
  • Familiarity with HIPAA

Legal Experience

  • Rule 13 Student Attorney, UMKC School of Law Child and Family Services Clinic, Interviewed and counseled multiple clients on Paternity and Custody matters under the direction of the Clinic Professor/Attorney., Represented five plus clients in Paternity Actions and Custody Modifications hearings before the Jackson County Family Court.
  • Guardian Ad Litem Certification, Guardian Ad Litem Course & Certification in Missouri, Actively participated in and completed all required coursework of the Guardian Ad Litem Workshop course while attending the UMKC School of Law.

Timeline

Clinical Trials Associate 2

IQVIA
01.2022 - 01.2024

Research Contracts Specialist

University of Kansas Medical Center Research Institute Research Contracts Office (KUMCRI)
01.2019 - 01.2021

Knowledge & Process Management Specialist

H&R Block Corporate
01.2018 - 01.2019

Client Service Representative-1

H&R Block Corporate
01.2018 - 12.2018

Judicial Law Clerk to the Honorable Bryan E. Round

Jackson County Sixteenth Circuit Court
01.2016 - 01.2017

Shift Manager

Beauty Brands Salon & Spa
07.2011 - 07.2013

Customer Service Specialist

Beauty Brands Salon & Spa
06.2010 - 07.2011

Bachelor of Arts - Psychology

The University of Kansas
Alannah Felix