Clinical Trial Associate, Senior Project Specialist

Parexel

. Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout .

Posted 9/24/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates foundational knowledge of clinical trial processes and drug development, with strong organizational skills and attention to detail. Proficient in managing study documentation and communication within study teams to ensure compliance and timely execution of clinical operations.

Highest-signal resume keywords

Clinical Operations SupportETMF Systems (VeevaVault)Drug Development KnowledgeMS Office Suite ProficiencyEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial ProcessStudy Management Tools DevelopmentQuality Checks on Trial DocumentsBudget Tracking ActivitiesStudy Sample Tracking

Soft Skills

Strong Organization SkillsInterpersonal SkillsAttention to DetailAbility to Prioritize TasksCollaboration Skills

Tools & Technologies

ETMF SystemsMS Office SuiteProject Tracking Tools

Industry Keywords

ICH-GCPCode of Federal RegulationsPharmaBiotechCRO Environment

About the role

Key responsibilities & impact

Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
Set up, organize and maintain study files and shared spaces in accordance with study requirements
Coordinate and track study training
Manage study sample and supply tracking and support interactions with vendors as needed
Support the Study Management team with specific projects
Communicate with study team members and identify and address study-related issues in collaboration with the study team
Perform routine quality checks on trial-level documents to ensure completeness and accuracy
Support timely, complete and compliant archiving in the TMF
Participate in company, departmental and project team meetings, including Investigator Meetings
Assist with basic financial and budget tracking activities related to the clinical trial

Requirements

What you’ll need

BS/BA degree or degree in healthcare field required
Experience supporting clinical operations activities in a similar role: 1+ years in a pharma or biotech organization or 2 years of experience in a CRO environment
Basic knowledge of drug development and clinical operations processes
Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and Code of Federal regulations
Effective written and verbal communication skills, with the ability to work collaboratively within study teams
Strong organization and interpersonal skills
Foundational experience with eTMF systems (VeevaVault preferred) and basic knowledge of essential documents to file study documents accurately with guidance
Strong attention to detail
Able to prioritize and manage multiple tasks with competing deadlines
High sense of urgency and commitment to excellence in the successful execution of deliverables
Demonstrates ability to identify issues and escalate appropriately to support timeline adherence
Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools