Summary
Overview
Work History
Education
Skills
Timeline
Generic

Samantha Porter

Kansasville,WI

Summary

Resourceful and dependable Clinical Trial Specialist with over 9 years of experience in the pharmaceutical, CRO, and medical device industries. Skilled in supporting cross-functional teams and project managers across multiple therapeutic areas, ensuring the successful execution of clinical trials. Recognized for consistently meeting deliverables while maintaining a high level of accuracy and compliance. Adept at managing multiple priorities in fast-paced environments, demonstrating strong problem-solving abilities and attention to detail. Committed to optimizing trial efficiency and contributing to the success of clinical research programs.

Overview

9
9
years of professional experience

Work History

Clinical Trial Specialist

Recor Medical
02.2022 - Current
  • Served as study lead for a post-approval, multi-site study, overseeing site activation, managing timelines, and ensuring regulatory and organizational objectives were met.
  • Led study start-up calls with cross-functional teams, facilitated and presented updates in core team and monthly study update meetings.
  • Acted as a vendor liaison, managing external partnerships and collaborating with commercial teams to optimize site activations and resource allocation.
  • Proposed process improvements, streamlining site activation workflows, revising templates to reduce document errors, and enhancing usability in TMF and CTMS systems.
  • Developed a Q&A document for a newly implemented TMF system and recommended updates to study-specific templates.
  • Supported BIMO audit preparations, served as scribe during an FDA audit, facilitated auditor requests, and ensured compliance with IRB submissions and regulatory documentation.
  • Managed IRB submissions and approvals for study-level documents, set up and maintained study regulatory binders, and conducted quality reviews to ensure audit readiness.
  • Assisted with site outreach, study interest questionnaires, NDA redlines, and site selection.
  • Provided support for budget negotiations, contract execution, and site activation tracking.
  • Created and shipped regulatory binders, and supported project-related equipment and shipments.
  • Tracked study-related information, including site status, enrollment, and regulatory documents.
  • Managed study email inboxes and trackers, ensuring timely responses and query resolution.
  • Reviewed site contracts, budgets, and invoices for compliance and financial accuracy.
  • Assisted CRAs with monitoring activities, regulatory submissions, and queries.
  • Proactively identified study challenges, engaging cross-functional teams to implement solutions.
  • Contributed to achieving key study milestones, including activating the first site by the FDA-set deadline and meeting corporate enrollment goals.

Clinical Trial Administrator

Arena Pharmaceuticals
01.2021 - 02.2022
  • Support Clinical Operations teams with ongoing conduct of studies while being familiar with ICH, GCP, appropriate regulations
  • Coordination and scheduling of study team meetings, vendor meetings and other large group meetings, prepared meeting agendas/transcribed minutes of meetings
  • Set up and maintain internal eTMF
  • Collection, routing, reviewing and tracking of clinical trial related documents such as country and site regulatory documents, letters of delegation, informed consent forms (ICFs), project plans, etc
  • Study startup activities such as review and approve essential documents to support site activation, review monitoring reports
  • Assist project teams with study specific documentation and guidelines as appropriate
  • Facilitate clinical trial insurance documentation and document translations
  • Collaborate with CRO, vendors and cross-functional counterparts; correspond with site staff and vendors
  • Assist w/site selection, participate in site engagement calls and SQVs
  • Submit and route contract requests (e.g., confidentiality agreements [CDAs], clinical trial agreements [CTAs])
  • Track and process vendor invoices
  • Onboard/train incoming CTAs

Clinical Project Coordinator

Celerion
07.2019 - 01.2021
  • Provide direct support to Project Managers throughout the duration of the study, including: study updates, assisting with Client and internal team meetings, review of Project Plans and CDAs
  • Maintains compliance with protocols covering patient care and clinical trial operations, including sending regulatory packets to sites, collection and tracking of regulatory documents during the start-up phase
  • Liaising with trial sites and Sponsors to facilitate daily trial activities and comply with research protocols
  • Support management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor expectations, in close cooperation with designated Project Team
  • Support Sponsor in fulfilling their obligations with regard to IRB submissions according to relevant regulatory requirements
  • Support in document management (creation, review, collection, filing, forwarding) including ICF's, submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure

Clinical Trial Assistant

Celerion
04.2018 - 07.2019
  • Followed informed consent processes and maintained records
  • Participate and support the site initiation, maintenance and close out activities of Celerion monitored projects in accordance with GCP and Celerion SOPs
  • Verification of essential document collection and maintenance, including initial and ongoing approval of monitor training and oversight
  • Support initial and ongoing training to the monitors and site personnel as needed and ensure documentation of all monitoring activities in a timely manner in accordance with SOP requirements.

Clinical Trial Assistant

ICON
04.2016 - 04.2018
  • Project Management Support - Producing and distributing meeting minutes (internal and sponsor); generating and distributing CTMS reports; tracking of document receipt and site IRB submissions; training/mentoring of study members; providing back-up support for ROW staff; responding to sponsor requests in a courteous and timely manner
  • Site Interaction - Distributing study materials to sites; communicating with sites about staff changes and study documents; drafting and sending electronic mass communications to sites; following up on data entry as instructed by CTMs during data locks
  • System Access Facilitation and Maintenance - Maintaining/reconciling/submitting documentation in Pfizer Trial Master File (PTMF), Maintaining information in RightTrackII (RTII) and Firecrest
  • Maintaining Clinical Study Documentation in eTMF - Submitting documents to eTMF

Education

Bachelor of Science - Health Sciences, Clinical Research Administration

George Washington University
Washington, DC
12-2026

Associate of Science - Liberal Arts And Sciences

Montgomery County Community College
Blue Bell, PA
05-2016

Skills

  • Microsoft Office Applications
  • Informed Consent review
  • Clinical trial management
  • IRB submissions
  • Good Clinical Practices
  • Training and mentoring
  • Site Feasibility
  • Attention to detail

Timeline

Clinical Trial Specialist

Recor Medical
02.2022 - Current

Clinical Trial Administrator

Arena Pharmaceuticals
01.2021 - 02.2022

Clinical Project Coordinator

Celerion
07.2019 - 01.2021

Clinical Trial Assistant

Celerion
04.2018 - 07.2019

Clinical Trial Assistant

ICON
04.2016 - 04.2018

Bachelor of Science - Health Sciences, Clinical Research Administration

George Washington University

Associate of Science - Liberal Arts And Sciences

Montgomery County Community College

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Samantha Porter