Overview
Work History
Education
Skills
Protocol Therapeutic Experience
Languages
Timeline
Generic

KELLY MOORE

Hollywood,FL

Overview

23
23
years of professional experience

Work History

SENIOR CLINICAL TRIALS COORDINATOR

EXECUPHARM INC./PAREXEL FSP UNDER ACCOMPLISHMENTS CONTRACT WITH MERCK
01.2018 - 05.2023
  • Communicated site performance with project team and assisted with implementing action plans for sites not meeting expectations, in conjunction with CRA and CRM
  • Served as one of the primary contacts for the project team and investigative sites, conducted sites contacts and documented contacts for assigned sites as required per study guidelines, including running contact reports for each site
  • Responsible for quality control and assurance as well as the preparation and resolution of findings for FDA and/or sponsor audits
  • Assisted CRAs with preparation for site visits (i.e., running reports, QC of site files (checking for missing documents), resolving action items from previous visits)
  • Demonstrated an understanding of the purpose of CTMS, eTMF, and the Shared Investigator Platform (SIP), how to use them and how to navigate within the different sections
  • Adhered to Good Clinical Practices, Operating Procedures and Regulatory Requirements
  • Consulted with internal and external customers (sponsor and investigative site personnel), and clinical supply/service vendors to meet project specific goals including participation in sponsor and project related meetings
  • Trained and mentored other CTCs
  • Collected and reviewed site regulatory documents required for IP release, study maintenance, and closeout
  • Involved in the site recruitment phase of SSU and have recruited over 250 sites for one study
  • Served as a CTC Subject Matter Expert (SME) for Study Start-Up
  • Served as the Liaison between sites and our internal contracts team with collection and finalization of the Confidentiality Disclosure Agreements (CDA)
  • Responsible for the development and upkeep/maintenance of various trackers such as the Protocol Specific Training Tracker, the Master Site Star-Up Tracker (MSST), Site and Country Essential Documents Tracker, etc
  • Responsible for running certain reports (i.e., CTMS Missing Data Report, Open Action Items Report) and sharing the findings with the team and CRM
  • Accomplishments: Became a Subject Matter Expert (Start-Up) for the entire CTC group (developed process improvements with the SME Team, created slide decks and gave presentations to the entire CTC group)
  • Received several “ExecuStars” (ExecuPharm’s recognition program for going beyond or a for a job done outstanding)
  • Nominee for Merck’s “You Made a Difference” Award (2021)
  • Top ten finalist for the Merck Innovation Challenge (2021)
  • Co-Submitter to the Merck Innovation Challenge (2022)
  • Activated first site three weeks prior to targeted/planned date.
  • Established strong relationships with clinical site personnel, promoting open communication channels for resolving concerns or clarifying questions throughout the study duration.
  • Worked collaboratively with external vendors to secure necessary resources and services for efficient trial operations.
  • Managed budgets for multiple clinical trials simultaneously, consistently delivering projects within allocated financial resources.
  • Achieved timely completion of study milestones by closely monitoring trial progress and addressing potential roadblocks.
  • Regularly reported study progress updates to senior management, facilitating informed decision-making regarding resource allocation or strategic direction changes as needed.
  • Streamlined trial processes with the creation of detailed study-specific procedures and guidelines.
  • Coordinated seamless handovers between different phases of trials, minimizing any delays or disruptions in study progression.
  • Mentored junior team members, fostering a collaborative work environment that encouraged ongoing professional development and growth.
  • Maintained a high level of ethical conduct throughout all aspects of clinical trials, ensuring adherence to Good Clinical Practice guidelines and other relevant regulations.
  • Improved communication between cross-functional teams, leading to increased efficiency in meeting project objectives.
  • Managed essential document storage, ensuring compliance with regulatory requirements and easy access for audits or inspections.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Self-motivated, with a strong sense of personal responsibility.
  • Paid attention to detail while completing assignments.
  • Demonstrated a high level of initiative and creativity while tackling difficult tasks.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Organized and detail-oriented with a strong work ethic.
  • Passionate about learning and committed to continual improvement.
  • Proven ability to learn quickly and adapt to new situations.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Developed and maintained courteous and effective working relationships.
  • Worked well in a team setting, providing support and guidance.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Participated in team projects, demonstrating an ability to work collaboratively and effectively.
  • Worked effectively in fast-paced environments.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Cultivated interpersonal skills by building positive relationships with others.
  • Excellent communication skills, both verbal and written.
  • Acted as a team leader in group projects, delegating tasks and providing feedback.

START-UP LEAD

PRA HEALTH SCIENCES
03.2014 - 06.2015
  • Supervised clinical operation tasks dedicated to the country startup progress of a project
  • Implemented the project start-up methodology including baseline, targeted and current subject recruitment months
  • Created, maintained, and facilitated Sponsor Approval of project documents related to study start-up (Startup plan, ICF checklist, essential document review requirements, site standard Investigational Product Release Forms)
  • Attended and presented study startup strategy/methodology at client kick off meetings
  • Functional team lead for study startup, attending all study team meetings (internal and with client/vendors)
  • Functional lead oversight of the IHCRA team during study startup activities (lead IHCRA team meetings during study startup, training, performance escalation, site assignments, and other various tasks)
  • Determined worked units and hours, analyzing forecasted and worked activities including identification, management, and escalation of out-of-scope work specific to the IHCRA study startup tasks
  • First point of escalation for IHCRA’s, and investigative sites during investigator recruitment and study startup activities
  • Accomplishments: IHCRA team survey rating of “Exceeds Expectations” on large phase 3 oncology study
  • Presented alternative recruitment strategy to address challenges with site activation timelines and cost for a non-small cell lung cancer study struggling with site interest due to competing studies
  • Exceeded site activation timelines on 75% of assigned studies.
  • Increased start-up efficiency by streamlining processes and implementing organizational systems.
  • Improved operational efficiency by identifying areas for improvement and implementing best practices across teams.
  • Followed informed consent processes and maintained records.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Demonstrated strong organizational and time management skills while managing multiple projects.
  • Strengthened communication skills through regular interactions with others.
  • Gained strong leadership skills by managing projects from start to finish.
  • Learned and adapted quickly to new technology and software applications.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Worked effectively in fast-paced environments.
  • Exercised leadership capabilities by successfully motivating and inspiring others.
  • Identified issues, analyzed information and provided solutions to problems.

SENIOR IN-HOUSE CRA

PRA HEALTH SCIENCES
03.2009 - 04.2014
  • Liaised with internal and external customers (sponsor and investigative site personnel), and clinical supply/service vendors to meet project specific goals including participation in sponsor and project related meetings
  • Supported Clinical Team Manager (CTM), Study Startup Lead (SUL), and Clinical Research Associate (CRA) in the management of investigational sites to ensure compliance with study timelines, the trial protocol, ICH/GCP and applicable regulations
  • Developed and reviewed Informed Consent Form (ICF) templates
  • Collected and reviewed site regulatory documents required for IP release, study maintenance, and closeout
  • Performed ongoing study tracking via CTMS or sponsor designated system to ensure that the study files were audit ready
  • Remote Monitoring for a Compassionate study: Responsible for completing and maintaining case report forms, regulatory, source documents and other documents
  • Creation and resolution of Data Clarification Forms
  • Other tasks include the collection and review of laboratory tests and procedures, as well as reduced error and risk by maintaining steady drug inventory and monitoring for compliance
  • Interviewed candidates for the ICRA role and participated post interview review discussions with the Clinical Operations Management team
  • Trained and mentored new IHCRAs
  • Accomplishments: Maintained 100% approval rate of IP release packages
  • Performed co-monitoring visits with CRAs with a focus on review of the site regulatory binder
  • Developed and implemented ICF tracking process for a large phase 3 CNS study with over 16 ICF’s/site
  • Promoted from IHCRA level 1 and 2.

PROJECT ASSOCIATE

PRA INTERNATIONAL
02.2008 - 02.2009
  • Managed project team and client meetings
  • Developed and maintained project documents and communication tools
  • Provided project management and operational support to designated clinical project teams ensuring that quality, timelines, and project specifications are met
  • Supplied shipments to investigative sites, preparing and submitted documents to the TMF
  • Managed study documentation ensuring accuracy within the documentation while aiding in the preparation of supply shipments to study sites
  • Setup, maintained, and updated databases and assisted with data query resolution
  • Performed quality control checks to ensure the integrity of data and supported initiation phase of project
  • Communicated with study sites by fielding, answering, and directing questions to obtain information and direct to corresponding personnel.

FOOD AND BEVERAGE CART ATTENDANT, BANQUET SERVER, AND FOH GRILL/CONSEESSION/BAR CASHIER

DEER CREEK GOLF CLUB
05.2003 - 12.2006
  • Banquet Server: Delivered exceptional customer service with a smile and cheerful outlook
  • Assisted with food preparation before and during the event
  • Served food and beverages to members and guests in a professional and timely manner
  • Set up tables and banquet hall before the event
  • Assisted with post-event clean up, inventory, food storage, and tear down
  • Anticipated member and guest’s needs and provided initiative-taking assistance throughout events
  • Worked collaboratively with the banquet team to ensure seamless event execution
  • Followed food safety and sanitation standards to maintain a clean and safe environment
  • Restocked items and supplies
  • Followed company policies and procedures
  • Food and Beverage Cart Attendant/Concessions/Bartender: Knowledgeable of the game of golf and provided golf etiquette when always approaching a golf group
  • Greeted members promptly by name if possible and made introductions with guests
  • Stocked cart with food, beverage, and ice before, during, and after shift
  • Recorded final inventory at end of shift and put products (food and alcoholic beverages) back in storage closet
  • Collected payments (i.e., cash, member charge, etc.) and accurately reconciled daily bank at the conclusion of each shift
  • Maintained proper knowledge of product, up selling where applicable
  • Requested and restocked, in a timely manner, to ensure proper par levels that allow for consistent and quality service
  • Cleaned and sanitized the cart of all food, ice, and trash at the end of each shift
  • Notified management of Member/Guest complaints at the time they occur
  • Ran up orders with POS and cash register
  • Kept the inside of concessions clean and fully stocked with food and all beverages
  • Prepared food for members/guests.

SERVER

FENTON’S BAR AND GRILL
06.2000 - 09.2003
  • Greeted guests promptly and courteously, reviewed specials, and menu options
  • Ran food to tables in a team effort
  • Explained menu items and terms and provided suggestions to guests when asked
  • Ensured Guest satisfaction throughout the meal service, including drink refills, pre-bussing, and removal of empty plates
  • Entered all food and beverage orders into Micros POS system
  • Delivered the check and processed payment promptly
  • Responsible for Up-sells on non-alcoholic and alcoholic beverages
  • Completed side work duties throughout shift
  • Maintained service station, before, during and after shift to ensure proper set-up and cleanliness
  • Maintained cooperative relationship with kitchen staff and other staff members in support of excellent communication and service
  • Comfortable working as a team in a fast-paced environment
  • Abide by all state, federal regulations and restaurant liquor policies pertaining to serving alcoholic beverages to minors and intoxicated guests.
  • Explained menu items and suggested appropriate options for food allergy concerns.
  • Upsold high-profit items such as appetizers and mixed drinks to enhance sales numbers.
  • Carried out complete opening, closing and shift change duties to keep restaurant working efficiently and teams ready to meet customer needs.
  • Resolved guest and employee complaints to maintain complete customer satisfaction and workforce effectiveness.
  • Maintained thorough menu knowledge to sufficiently answer questions regarding menu item sourcing, ingredients and cooking methods.
  • Assisted in training new hires, providing guidance on restaurant standards and best practices.
  • Monitored patrons for alcohol intake to appropriate levels and took measures to curtail inappropriate behavior.
  • Learned and followed local alcohol laws to keep restaurant compliant with regulations while serving spirits.
  • Demonstrated strong multitasking skills by managing multiple tables simultaneously without compromising service quality.
  • Consistently met or exceeded performance goals related to sales targets, customer satisfaction ratings, and order accuracy.
  • Cultivated warm relationships with regular customers.
  • Increased sales with upselling techniques and thorough knowledge of menu items, specials, and promotions.
  • Contributed to inventory management by monitoring stock levels and notifying management when supplies were low.
  • Coordinated with kitchen staff to ensure timely delivery of orders, resulting in satisfied customers.
  • Enhanced customer satisfaction by promptly attending to their needs and providing personalized service.
  • Strategically timed check-ins with customers to take orders and confirm satisfaction with meals after delivery, taking action to correct any problems.
  • Supported colleagues during peak hours, fostering a collaborative work environment that enhanced overall productivity levels.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Paid attention to detail while completing assignments.
  • Skilled at working independently and collaboratively in a team environment.

Education

No Degree - Dietetics

Kansas State University
Manhattan, KS

High School Diploma -

Olathe East Sr. High School
Olathe, KS
05.2001

Skills

  • Protocol Review
  • Clinical trial management
  • Research experience
  • Good Clinical Practices
  • Documentation requirements
  • Informed consent
  • Standard Operating Procedures
  • Regulatory Submissions
  • Multitasking proficiency
  • Adverse event reporting
  • Site Selection
  • Study protocols
  • Informed Consent Process
  • Trial management
  • Training and mentoring
  • Clinical Research Ethics
  • Computer Skills
  • Organization and Time Management
  • Problem-Solving
  • Relationship Building
  • Team building
  • Friendly, Positive Attitude
  • Time Management
  • Organization
  • Microsoft Office
  • Critical Thinking
  • Dependable and Responsible
  • Research
  • Multitasking
  • Electronic Data Capture
  • Oncology

Protocol Therapeutic Experience

Gastroenterology

Esophageal Disorders: GERD   2yrs


Immunology

Allergy: Allergy   (non-respiratory) 1.5yrs

Autoimmune Disorders:   Ulcerative Colitis 1.75yrs


Neurology

Dementia: Alzheimer’s   Disease 3.25yrs

Pain: Back Pain and Chronic   Pain 4yrs


Oncology

Solid Tumors: Non-small   Cell Lung Cancer and Renal Cell Carcinoma 2.5yrs

Hematology: 2yrs

Other: 5 years


Psychiatry

Mood Disorders: Depression   2.5yrs

Substance   Use Disorders: Opioid .75yrs



Languages

English
Native or Bilingual
Spanish
Elementary

Timeline

SENIOR CLINICAL TRIALS COORDINATOR

EXECUPHARM INC./PAREXEL FSP UNDER ACCOMPLISHMENTS CONTRACT WITH MERCK
01.2018 - 05.2023

START-UP LEAD

PRA HEALTH SCIENCES
03.2014 - 06.2015

SENIOR IN-HOUSE CRA

PRA HEALTH SCIENCES
03.2009 - 04.2014

PROJECT ASSOCIATE

PRA INTERNATIONAL
02.2008 - 02.2009

FOOD AND BEVERAGE CART ATTENDANT, BANQUET SERVER, AND FOH GRILL/CONSEESSION/BAR CASHIER

DEER CREEK GOLF CLUB
05.2003 - 12.2006

SERVER

FENTON’S BAR AND GRILL
06.2000 - 09.2003

No Degree - Dietetics

Kansas State University

High School Diploma -

Olathe East Sr. High School

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KELLY MOORE