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Parexel

Research Associate, ICRA

Parexel

. Manage site start-up activities from feasibility and qualification through site activation .

Posted 10/26/2026full-timeRemote • Brazil, Argentina, MexicoJuniorMid-LevelWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in managing clinical trial site start-up activities, ensuring compliance with Good Clinical Practice guidelines and local regulations while maintaining high-quality documentation. Proficient in stakeholder management and communication to facilitate project milestones and site readiness.

Highest-signal resume keywords
Clinical Research ExperienceSite Start-Up ManagementRegulatory Document PreparationClinical Trial Management SystemsGood Clinical Practice Knowledge

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 ManagementRegulatory Document ExecutionSite Activation StrategiesData Quality ManagementTrial Master File ProcessesMicrosoft Office ToolsInformed Consent FormsConfidentiality Disclosure AgreementsSite Issue ResolutionProject Timeline Management
Soft Skills
Strong Communication SkillsOrganization SkillsPresentation SkillsStakeholder ManagementProblem-Solving Skills
Tools & Technologies
Electronic Trial Master File SystemsClinical Trial Management Systems
Industry Keywords
Good Clinical PracticeRegulatory AuthoritiesInstitutional Review BoardsIndependent Ethics CommitteesHealth-Related Fields

About the role

Key responsibilities & impact
  • Manage site start-up activities from feasibility and qualification through site activation
  • Build working relationships with investigators and site staff as the primary contact for assigned sites
  • Prepare, review, negotiate, and execute regulatory and site documents, including confidentiality disclosure agreements, informed consent forms, translations, and amendments
  • Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities
  • Develop and track site activation strategies, timelines, and regulatory plans
  • Maintain accurate, high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems
  • Identify, resolve, or escalate site issues and risks related to activation, recruitment, compliance, training, and data quality
  • Support sites with study system access, training requirements, and readiness activities
  • Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle
  • Maintain compliance with Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures
  • Collaborate across functions to achieve project milestones and deliverables, communicating progress, risks, and issues

Requirements

What you’ll need
  • Strong clinical research and study start-up experience
  • Strong knowledge of clinical trial management systems, electronic trial master file systems, trial master file processes, and Microsoft Office tools
  • Knowledge of International Council for Harmonization Good Clinical Practice guidelines, local regulatory requirements, sponsor requirements, and clinical trial start-up processes
  • Excellent oral and written English skills
  • Strong communication, organization, presentation, stakeholder management, and problem-solving skills
  • Ability to work independently, prioritize multiple tasks, and make sound decisions in ambiguous situations
  • Experience working in global, matrix, and multicultural environments
  • High attention to detail and strong quality focus
  • Commitment to achieving project timelines
  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or another health-related field, or equivalent experience, is preferred

Benefits

Comp & perks
  • Home-based work with flexibility
  • Dedicated line manager support
  • Strongly connected team environment
  • Opportunities to deepen expertise across global study start-up and regulatory operations
  • Flexible work culture
  • Growth opportunities