Clinical Trial Coordinator – FSP

Parexel

. Support the Clinical Research Manager and other team members throughout the study lifecycle from study start-up to study closure .

Posted 10/27/2026full-timeRemote • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research support, including managing clinical trial documentation, compliance with ICH-GCP guidelines, and effective communication with stakeholders. Proficient in budget development, tracking, and negotiation within a multicultural environment.

Highest-signal resume keywords

Clinical Research SupportICH-GCP KnowledgeBudget Development and TrackingGood Documentation PracticesMS Excel Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Documentation ManagementBudget Calculation and ExecutionElectronic Trial Master File ReconciliationClinical Database UpdatingLabeling Requirements ManagementInvestigator Trial File PreparationSafety Report TrackingDocument Translation CoordinationCompliance TrackingInsurance Certificate Management

Soft Skills

Effective CommunicationTime ManagementOrganizational SkillsInterpersonal SkillsConflict Management

Tools & Technologies

MS OfficeClinical IT ApplicationsTracking ToolsContract Templates

Industry Keywords

Clinical ResearchGlobal Clinical Research GuidelinesInstitutional Review BoardEthics Review CommitteeForeign Corrupt Practices Act Compliance

About the role

Key responsibilities & impact

Support the Clinical Research Manager and other team members throughout the study lifecycle from study start-up to study closure
Track essential documents and report safety reports
Collate and distribute study tools and documents
Update clinical trial databases and trackers
Manage clinical and non-clinical supplies in collaboration with country roles
Manage labeling requirements and coordinate/sign translation change requests
Prepare, collate, distribute, ship, and archive clinical documents and correspondence
Assist with electronic Trial Master File reconciliation and execute the electronic Trial Master File Quality Control Plan
Update manuals and documents and obtain document translations
Document proper destruction of clinical supplies
Prepare Investigator trial file binders
Provide and collect investigator forms/lists for site evaluation, validation, start-up, and submissions
Obtain, track, and update study insurance certificates
Support Institutional Review Board/Ethics Review Committee and regulatory agency submissions
Publish study results where required by local legislation
Develop country and site budgets and track negotiations
Maintain tracking tools and contract templates
Support contract development, negotiation, approval, and maintenance
Calculate and execute payments to investigators, vendors, and grants
Ensure compliance with financial procedures and track adherence and disclosures
Complete budget closeout and process Foreign Corrupt Practices Act documentation
Organize meetings and support local investigator meetings
Complete required training, timesheets, expense reports, and CV updates
Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements
Contribute to team knowledge by mentoring and sharing best practices

Requirements

What you’ll need

Candidates should have 1-2 years of experience in clinical research
Fluent in Local Languages and business proficient in English (verbal and written)
Good understanding of Global, Country/Regional Clinical Research Guidelines
Hands on knowledge of Good Documentation Practices
Good IT skills, including MS Office and clinical IT applications
Strong MS Excel skills
International Council for Harmonization – Good Clinical Practice knowledge appropriate to role
Effective time management, organizational, interpersonal, and conflict management skills
Effective communication with external customers, including sites and investigators
Ability to set priorities and handle multiple tasks simultaneously in a changing environment
Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships
Able to work independently
Proactive attitude to solving problems and proposing solutions
Bachelor’s degree (Life Sciences preferred) or equivalent healthcare experience