Joshua Goff
Ogden,UT
Summary
I excel in leveraging advanced Excel and SQL skills to enhance data analysis and reporting, achieving significant efficiency improvements. My expertise in site management and adherence to ICH GCP guidelines ensures top-notch clinical trial oversight. Known for developing impactful training programs, I blend technical prowess with strong collaborative abilities.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate
Thermo Fisher
Ogden, Utah
03.2023 - Current
- Subject Matter Expert in Microsoft Excel.
- Create, implement, and train on highly customized Excel dashboards and templates, leveraging advanced functions and automation to streamline data analysis and reporting, significantly improving efficiency and data accuracy.
- Regularly provided comprehensive training and demonstrations of Excel tools and their functionalities to over 70 colleagues.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Conducts site initiation visits, site monitoring visits, and study close-out visits, and monitors ongoing studies at investigator sites to determine protocol and regulatory compliance, and prepares required documentation.
- Interfaced directly with a large pharmaceutical/biotech company by collaborating and supporting the local and central study management project teams.
- Coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.
- Develops collaborative relationships with investigative sites and client company personnel.
- Created and administered corrective training to site staff to address protocol deviations.
Clinical Research Coordinator II/Lead CRC
Thermo Fisher
Ogden, Utah
01.2022 - 03.2023
- Created Excel-based tools customized to individual clinical studies to streamline and automate investigational product accountability, which increased efficiency and accuracy. These tools were later used as audit preparation tools.
- Screened potential study subjects and verified their eligibility against study-specific eligibility criteria.
- Obtaining informed consent from potential study subjects.
- IP accountability (storing dispensing, preparing, and administering investigational product to study subjects).
- Scheduling various study-related medical procedures, such as MRIs and liver biopsies.
- Reported SAEs and protocol deviations for studies to the IRB.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Obtained vital signs and collected medical histories as part of study protocols.
- Adhered to ICH GCP standards in areas involving data collection, research protocols, and regulatory reporting.
- Worked with the study team, department, sponsors, and institutions to support and provide guidance on the administration of compliance, financial, personnel, and other related aspects of the clinical study.
Clinical Research Coordinator
Utah Cancer Specialists
Murray, Utah
10.2021 - 01.2022
- Supported, facilitated, and coordinated daily clinical trial activities.
- Screened potential study subjects and verified their eligibility against study-specific eligibility criteria.
- Obtaining informed consent from potential study subjects.
- Performed investigational product (IP) accountability (storing, dispensing, preparing, and administering investigational product to study subjects).
- Scheduled various study-related medical procedures, such as MRIs.
- Reported serious adverse events (SAEs) and protocol deviations for studies to the IRB.
- Worked with the study team, department, sponsors, and institution to support and provide guidance on the administration.
- Kept patient care protocols and clinical trial operations in compliance.
Research Regulatory Coordinator
Intermountain Healthcare
Murray, Utah
04.2021 - 11.2021
- Supported, facilitated, and coordinated daily clinical trial activities.
- Collaborated with other departments to create effective protocols for submitting documentation.
- Regular communication with the Institutional Review Board (IRB), including submissions, query resolution, and making amendments to study documents.
- Collaborated across internal departments to achieve regulatory objectives and maintain ICH GCP compliance.
- Maintained up-to-date study documents in hardcopy and electronic format.
- Reported SAEs and protocol deviations to the IRB.
- Worked with the study team, department, sponsors, and institution to support and provide guidance on the administration of compliance, financial, personnel, and other related aspects of the clinical study.
Clinical Research Coordinator
Intermountain Healthcare
Layton, Utah
06.2018 - 04.2021
- Supported, facilitated, and coordinated daily clinical trial activities.
- Screened potential study subjects and verified their eligibility against study-specific eligibility criteria.
- Obtained informed consent from potential study subjects.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Took vital signs and collected medical histories as part of study protocols.
- Provided guidance on Good Clinical Practice regulations and other applicable regulatory standards.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Reported SAEs and protocol deviations to the Institutional Review Board (IRB).
- Worked with the study team, department, sponsors, and institution to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
Education
Bachelor of Science - Zoology
Weber State University
Ogden, UT04-2017
Associate of Science - Zoology
Weber State University
Ogden, UT04-2016
Skills
- Advanced Excel functions
- Excel and SQL mastery
- Advanced Excel knowledge
- Advanced Microsoft Excel
- Excel Spreadsheet Development
- Visual data representation
- Data filtering
- Data validation
- Data formatting
- Data quality assurance processes
- Site management
- Action planning
- ICH guidelines
- Monitoring visits
- IRB submissions
- Good clinical practice
Affiliations
- Gardening
- Martial Arts
- Home Improvement
- Story-telling
- table-top games
- Archery
- Axe Throwing
Languages
English
Native/ Bilingual
Norwegian
Professional
References
References available upon request.
Timeline
Clinical Research Associate
Thermo Fisher
03.2023 - Current
Clinical Research Coordinator II/Lead CRC
Thermo Fisher
01.2022 - 03.2023
Clinical Research Coordinator
Utah Cancer Specialists
10.2021 - 01.2022
Research Regulatory Coordinator
Intermountain Healthcare
04.2021 - 11.2021
Clinical Research Coordinator
Intermountain Healthcare
06.2018 - 04.2021
Bachelor of Science - Zoology
Weber State University
Associate of Science - Zoology
Weber State University