Senior Clinical Trial Associate

United StatesRemoteFull-timesenior

OtherClinical Trial Associate

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Quick Summary

Overview

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Trial Associate based in United States.

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OtherClinical Trial Associate

This role supports the successful planning, execution, and closeout of clinical studies in a regulated clinical operations environment. You’ll work closely with Clinical Trial Managers and cross-functional teams to help ensure studies are conducted according to protocols, Good Clinical Practice, and applicable regulatory requirements. Your responsibilities will span study start-up, site coordination, documentation, trial administration, and operational support throughout the study lifecycle. You’ll collaborate with teams across Research and Development, Regulatory, Safety, and Quality/Compliance. The position offers the opportunity to contribute to moderately complex clinical projects while developing strong expertise in clinical trial operations. This is a remote role suited to an organized, independent professional with strong communication skills and attention to detail.

Support Clinical Trial Managers and Senior Clinical Trial Managers with activities required before clinical trials begin, including clinical planning, protocol development, case report form development, IRB submissions, investigator agreements, informed consent documentation, site selection, and Trial Master File preparation.
Coordinate with clinical trial sites regarding administrative documentation, study materials, training, and other start-up requirements.
Support clinical operations teams in maintaining compliance with FDA and applicable international regulations, Good Clinical Practice requirements, and internal standard operating procedures throughout clinical investigations and post-market studies.
Assist with communication and coordination with clinical trial sites regarding study conduct, monitoring activities, follow-up visits, and study closeout activities.
Help ensure study activities and site interactions remain aligned with clinical protocols and GCP requirements.
Assist with tracking study-related payments, invoices, and other financial or administrative documentation.
Provide operational and workflow support to ensure departmental and cross-functional systems, processes, and procedures are completed accurately and efficiently.
Collaborate with cross-functional project teams, including Research and Development, Regulatory, Safety, and Quality/Compliance.
Maintain and support administrative documentation for clinical study programs, Trial Master Files, and study start-up activities.
Assist Clinical Trial Managers and clinical operations teams with preparing and presenting clinical information related to assigned projects.
Contribute to projects of moderate to high complexity, applying sound judgment, analytical thinking, flexibility, and problem-solving skills as required.

Requirements

~1 min read

Bachelor’s degree in a health profession, life science, or related scientific discipline; an advanced degree is a plus.
At least 3 years of clinical trial experience, with demonstrated involvement in ongoing clinical studies.
Solid understanding of Good Clinical Practice (GCP) principles and FDA regulatory requirements.
Knowledge of medical terminology and clinical research processes.
Ability to work independently, manage responsibilities effectively, and exercise sound judgment in a regulated environment.
Excellent written and verbal communication skills, with the ability to collaborate effectively with clinical sites and cross-functional stakeholders.
Strong organizational skills and attention to detail, particularly when managing study documentation, timelines, and administrative requirements.
Computer proficiency, including Microsoft Word, Excel, and Outlook.
Ability to contribute effectively within multidisciplinary project teams.
Comfortable handling projects that require analytical thinking, flexibility, prioritization, and appropriate independent decision-making.
Willingness to travel occasionally, as required.
Must be authorized to work for any U.S. employer; visa sponsorship or transfer of sponsorship is not available.