Research Associate – ICRA

Parexel

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

Posted 10/22/2026full-timeRemote • Argentina, Mexico, BrazilJuniorMid-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 and effective communication with stakeholders.

Highest-signal resume keywords

Clinical Research ExperienceSite Start-Up ManagementRegulatory Document PreparationClinical Trial Management SystemsStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory SubmissionsSite Activation StrategiesTrial Master File ProcessesGood Clinical Practice GuidelinesData Quality ManagementProject Timeline ManagementInformed Consent FormsConfidentiality Disclosure AgreementsElectronic Trial Master File Systems

Soft Skills

Problem-SolvingCommunicationPresentationOrganizationAttention to Detail

Tools & Technologies

Microsoft Office ToolsClinical Trial Management SystemsElectronic Trial Master File Systems

Industry Keywords

International Council for HarmonizationRegulatory AuthoritiesInstitutional Review BoardsIndependent Ethics CommitteesSponsor Requirements

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 to support project milestones
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
Excellent problem-solving, communication, presentation, and stakeholder management 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
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

Benefits

Comp & perks

Home-based role with flexibility that working from home offers
Dedicated line managers and a strongly connected team
Opportunities to deepen expertise across global study start-up and regulatory operations
Flexibility and growth opportunities