Senior Clinical Research Specialist

Merit Medical Oncology

Senior Clinical Research Specialist managing clinical trial documentation and compliance at Merit Medical. Overseeing regulatory documents, supporting study vendors, and assisting in clinical trials.

Posted 6/17/2026full-timeRemote • Utah • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Sets up and maintains trial master file and is responsible for filing and maintaining up to date study documents.
Maintains multiple trackers following the progress of assigned clinical trials, such as essential documents, investigational product, trial supplies and study follow-up visits, as applicable.
Orders, prepares, and sends documents and materials to clinical trial sites and vendors as needed (electronic and paper).
Provides support to study vendors.
Collects and reviews all regulatory documents for accuracy and compliance to departmental SOPs, local and national regulations and guidelines.
Follows up as required to resolve deficiencies.
Ensures that regulatory documents are maintained and updated in a timely and appropriate manner.
Ensures study team training records are kept current.
Performs in-house duties to assist monitors, e.g., outstanding action items.
Manages central IRB submissions and supports sites in IRB/EC submissions.
May attend site visits to assist monitors, when applicable.
Assists with the development of study and site tools.
Contributes to clinical site interactions, including enrollment and subject visit updates, clinical trial material and clinical supply requests, issue resolution, etc.
Assists in developing and overseeing study operational plan(s) as applicable (e.g., TMF plan).
Contributes to study team for trial start-up, conduct, and close-out activities according to industry and departmental standards.
Conducts study systems training(s).
Contributes to creation of study documentation including informed consent, newsletters, etc.
Provides general support to the Clinical Affairs team and project team(s), including meeting agendas, minutes and management of translations.
Assists Project Managers with invoice receipt and review as applicable.
Performs other duties and tasks, as required.

Requirements

What you’ll need

Education and/or experience equivalent to a Bachelor's Degree in a scientific discipline or nursing qualification
A minimum of six (6) years of related work experience
Current Good Clinical Practice (GCP) certification
Knowledge of US regulations, Good Clinical Practice and ICH guidelines
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs
Clinical trial experience.

Benefits

Comp & perks

Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
401K | Health Savings Account

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementregulatory document reviewstudy documentation creationstudy operational planningdata trackingissue resolutionstudy systems trainingclinical supply managementenrollment managementtrial master file maintenance

Soft Skills

communicationorganizational skillsattention to detailproblem-solvingteam collaborationtime managementsupportive interactionadaptabilitytraining facilitationmeeting management

Certifications

Good Clinical Practice (GCP) certification