Clinical Trial Coordinator – FSP

Parexel

. Support the Clinical Research Manager and other team members throughout the study life cycle, 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 Management, including proficiency in Clinical Trial Management Systems (CTMS), Good Clinical Practice (GCP), and regulatory submissions. Strong organizational and communication skills are essential for effective collaboration in a multicultural environment.

Highest-signal resume keywords

Clinical Trial Management Systems (CTMS)Good Clinical Practice (GCP)Good Documentation PracticesMS ExcelClinical Research Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Management Systems (CTMS)Good Clinical Practice (GCP)Good Documentation PracticesMS ExcelClinical ResearchRegulatory SubmissionsStudy Budget ManagementETMF Quality ControlInvestigator Trial File PreparationSafety Reporting

Soft Skills

Effective CommunicationTime ManagementOrganizational SkillsInterpersonal SkillsConflict Management

Tools & Technologies

Clinical IT ApplicationsMS OfficeElectronic Trial Master File (eTMF)Study Tracking Tools

Industry Keywords

Clinical ResearchLife SciencesEthics Review CommitteeForeign Corrupt Practices ActMulticultural Environment

About the role

Key responsibilities & impact

Support the Clinical Research Manager and other team members throughout the study life cycle, from study start-up to study closure
Track essential documents and report safety reports
Collate and distribute study tools and documents
Update clinical trial management systems (CTMS) and trackers
Manage clinical and non-clinical supplies in collaboration with country roles
Manage labeling requirements and coordinate translation change requests
Prepare, distribute, ship, archive, and quality-control clinical documents
Assist with electronic Trial Master File (eTMF) reconciliation and execute the eTMF Quality Control Plan
Prepare Investigator Trial File binders and update manuals and documents
Obtain translations and document proper destruction of clinical supplies
Provide and collect investigator forms/lists for site evaluation, validation, start-up, and submissions
Obtain, track, and update study insurance certificates
Support IRB/Ethics Review Committee submission packages and regulatory agency submissions
Publish study results where required by local legislation
Collaborate with finance/budgeting representatives on country and site budgets, negotiations, tracking tools, contracts, payments, financial compliance, disclosures, and budget closeout
Obtain and process Foreign Corrupt Practices Act documentation
Organize meetings and study memos, letters, and protocols
Support local investigator meetings, including invitations, materials, venue selection, and logistics
Complete assigned Client and Parexel training and adhere to SOPs and processes
Contribute to team knowledge by mentoring/buddying and sharing best practices

Requirements

What you’ll need

B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
Hands on knowledge of Good Documentation Practices
Good IT skills, including use of MS Office and clinical IT applications; strong MS Excel skills required
International Committee on Harmonization (ICH) Good Clinical Practice (GCP) 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 establish culturally sensitive working relationships
Ability to work independently
Proactive attitude toward solving problems and proposing solutions
Fluent in local languages and business proficient in English, verbal and written
Excellent communication skills