Site Activation Partner – Study Start-Up Associate

Parexel

. Initiate and coordinate clinical trial site activation activities and essential document management .

Posted 10/23/2026full-timeRemote • AustraliaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial site activation, regulatory document preparation, and compliance with ICH-GCP and FDA regulations. Proficient in managing clinical documentation and coordinating with investigators and ethics committees to ensure timely approvals and site readiness.

Highest-signal resume keywords

Clinical Trial Management Systems (CTMS)Regulatory Document PreparationICH-GCP ComplianceSite Activation CoordinationClinical Research Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesBasic Medical TerminologyDocument ManagementQuality ControlSite Compliance TrackingProtocol AmendmentsFDA 1572/Attestation FormsInvestigator Initiation PackagesEthics Committee SubmissionsMultitasking

Soft Skills

Attention to DetailEffective CommunicationTeam CollaborationProblem SolvingOrganizational Skills

Tools & Technologies

Microsoft SuiteElectronic Trial Master FileElectronic Investigator Site FileShared Investigator PlatformDocument Exchange Portals

Industry Keywords

Clinical ResearchPharmaceutical IndustryCRO ExperienceRegulatory ComplianceSite Management

About the role

Key responsibilities & impact

Initiate and coordinate clinical trial site activation activities and essential document management
Compile high-quality Investigator Initiation Packages leading to site initiation approval
Resolve or escalate site issues in a timely manner
Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
Coordinate supporting roles and activities to ensure timely site activation
Support central and local ethics committee packages, submissions, communications, and approvals
Support investigators with local IRB workflows from preparation through approval
Prepare, handle, and distribute clinical documentation and reports according to scope of work and SOPs
Support and implement activities in the Shared Investigator Platform
Manage site documentation and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
Maintain IRB/Ethics and other committee activities as applicable
File documents to the Trial Master File and assist with periodic quality reviews
Update and maintain clinical trial systems tracking site compliance and performance
Support investigator sites and study teams during audits and inspections
Maintain communication with study teams and investigator sites and respond to requests
Provide country- and site-level functional updates and establish tools for efficient status reporting
Disseminate central and local ethics approvals to study teams and investigator sites
Conduct awareness sessions on client requirements and ongoing documentation compliance as needed
Identify and resolve site issues and coordinate corrective and preventative actions
Serve as a Site Activation Partner point of contact, subject matter expert, mentor, or representative on initiatives as assigned
Complete required training, timesheets, expense reports, and CV updates
Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

Requirements

What you’ll need

Knowledge of clinical research and development processes and key operational elements of a clinical trial
Understanding of quality expectations and emphasis on right first time
Compliance with applicable company, regulatory, and country requirements
Disciplined attention to detail
Ability to work independently and as a team member
Ability to organize tasks, time, and priorities and multitask
Basic medical terminology and GCP requirements
Proficient in computer operations and able to learn and use systems independently
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Trial Master File and Electronic Investigator Site File systems, e.g. Florence
Document exchange portals
Shared Investigator Platform
Ethics, national networks, and governing bodies portals and platforms as needed
Flexibility for off-hours work in a global environment when applicable
Able to travel as needed, including possible international travel
Experience in the 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
Multilanguage capability preferred
Effective verbal and written communication skills
Good technical skills and ability to learn and use multiple systems
School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent
Minimum 2 years of relevant experience in clinical site management
Education in a life sciences discipline preferred

Benefits

Comp & perks

No benefits, perks, or compensation extras are specified in the posting