Clinical Research Assistant

Therapeutics Inc.

. Provide multi-task administrative support to clinical personnel for implementation of clinical studies .

Posted 10/8/2026full-timeSan Diego • California • United StatesMid-LevelSenior💰 $66,500 - $68,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates strong administrative support capabilities in clinical research, including proficiency in Clinical Trial Management Systems (CTMS) and a thorough understanding of GCPs and ICH regulatory guidelines. Effective in managing study documentation, communication, and multi-tasking within clinical study environments.

Highest-signal resume keywords

Clinical Trial Management System (CTMS)Good Clinical Practice (GCP)International Council for Harmonisation (ICH)Regulatory Document ManagementMulti-Tasking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRegulatory Document ManagementStudy DocumentationTMF ReviewsStudy CloseoutData ArchivingStudy SetupSubject Enrollment ManagementMeeting Agenda DevelopmentCommunication with Internal Departments

Soft Skills

Excellent Written CommunicationExcellent Oral CommunicationDetail-OrientedOrganizational SkillsAbility to Handle Multiple Tasks

Certifications & Qualifications

BS Degree or Equivalent

Industry Keywords

Clinical StudiesClinical ResearchRegulatory GuidelinesTherapeutic AreasInvestigator Meetings

About the role

Key responsibilities & impact

Provide multi-task administrative support to clinical personnel for implementation of clinical studies
Assist with start-up of new clinical studies and generate, distribute, and obtain required study documents
Set up and maintain central filing systems for regulatory documents and study records
Maintain and track study site clinical supplies and associated documentation
Assist with investigator meetings and develop/distribute meeting agendas and minutes
Develop and maintain communication with internal and external departments/offices
Set up new studies in the Clinical Trial Management System (CTMS) and track regulatory documents
Assist CRAs with study closeout through TMF reviews and closeout binders
Archive TMF and related project files for completed studies
Develop knowledge of therapeutic areas through journals, seminars, and clinical protocols
Assist with communications, recruitment packages, subject enrollment logs, and weekly project management updates

Requirements

What you’ll need

BS degree or equivalent knowledge and experience
Some experience in clinical research or the medical field, or the education and passion to develop within the industry
Excellent written and oral communication skills
Ability to handle multiple tasks easily
Detail-oriented
Comfortable navigating computer programs
Thorough knowledge of GCPs, ICH and other regulatory guidelines to be developed/understood for clinical studies