Site Activation Partner I

Parexel

. Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites .

Posted 9/18/2026full-timeRemote • Brazil, Argentina, MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical site management, regulatory document preparation, and compliance with ICH/GCP and FDA regulations. Proficient in coordinating site activation activities and maintaining effective communication with study teams and investigator sites.

Highest-signal resume keywords

Clinical Site ManagementRegulatory Document PreparationICH/GCP ComplianceClinical Trial MethodologiesSite Activation Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesRegulatory Document PreparationBasic Medical TerminologyGCP RequirementsAttention to Detail

Soft Skills

Effective Verbal CommunicationEffective Written CommunicationAbility to MultitaskOrganizational SkillsTeam Collaboration

Tools & Technologies

Microsoft SuiteCTMSElectronic Trial Master FileElectronic Investigator Site FileDocument Exchange Portals

Industry Keywords

Clinical ResearchPharmaceutical IndustryCROIRBFDA Regulations

About the role

Key responsibilities & impact

Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites
Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site initiation approval
Register and maintain investigator sites and client stakeholders in required registries and systems
Interact with investigator sites to confirm readiness for start-up and review site profiles, essential documents, contracts, clinical supplies, payments, and IRB status
Resolve and escalate site issues and concerns
Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
Coordinate supporting roles and activities for timely site activation
Support central and local IRB submissions, ethics committee communications, approvals, and workflows
Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving
Support eISF readiness and manage site and monitor access before Site Initiation Visits
Coordinate document translation with preferred vendors
Manage post-activation documents and updates throughout the study lifecycle, including protocol amendments and ethics approvals
Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
Update clinical trial systems tracking site compliance and performance
Support site audits and inspections
Maintain communication with study teams and investigator sites and provide country/site updates
Disseminate ethics and local site approvals to study teams and stakeholders
Conduct awareness sessions on client requirements and documentation compliance as needed
Identify and resolve investigator site issues and coordinate corrective and preventative actions
Complete assigned training and adhere to Parexel and client SOPs and processes
Potentially serve as study point of contact, subject matter expert, global initiative representative, or mentor

Requirements

What you’ll need

School diploma/certificate with equivalent combination of education, training and experience required; Bachelor of Science, Bachelor of Arts or Bachelor’s in Life Sciences preferred
Minimum 3 years’ relevant experience in clinical site management, working with US/Canada
Experience in pharmaceutical industry or CRO in study site activation preferred
Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations
Fluent in the local language and English
Effective verbal and written communication skills
Good technical skills and ability to learn and use multiple systems
Knowledge of clinical research and development processes and key operational elements of a clinical trial
Understanding of quality expectations and right-first-time principles
Compliance with company, regulatory, and country requirements
Attention to detail and disciplined approach
Ability to work independently and as a team member
Ability to organize tasks, time, and priorities and multitask
Basic medical terminology knowledge, GCP requirements, and proficient computer operations
Ability to use and learn Microsoft Suite, CTMS, electronic Trial Master File, electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics/national networks/governing body portals

Benefits

Comp & perks

Training assigned by Client and/or EP, including general training, SOP, system and process-related training
Mentoring opportunities for new hires on processes/systems
Multilanguage capability preferred