Site Activation Partner I – FSP, Fixed-Term 7 months

Parexel

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

Posted 9/18/2026full-timeRemote • CanadaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including site activation, compliance with ICH-GCP and FDA regulations, and effective communication with stakeholders. Proficient in managing essential documents and utilizing clinical trial management systems to ensure high-quality study execution.

Highest-signal resume keywords

Clinical Trial Management Systems (CTMS)ICH-GCP ComplianceSite Activation ExperienceRegulatory Document PreparationEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research KnowledgeRegulatory Document SubmissionBasic Medical TerminologyAttention to DetailMultitasking AbilityProficiency in Microsoft SuiteExperience with Electronic Trial Master FileExperience with Shared Investigator PlatformKnowledge of Clinical Trial MethodologiesFluency in English

Soft Skills

Ability to Work IndependentlyTeam CollaborationOrganizational SkillsEffective Verbal CommunicationWritten Communication Skills

Tools & Technologies

Electronic Investigator Site File SystemsDocument Exchange PortalsClinical Trial Management SystemsShared Investigator PlatformEthics Committee Portals

Industry Keywords

Pharmaceutical IndustryCRO ExperienceStudy Site ActivationCompliance with Regulatory RequirementsLocal and Global 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
Ensure compliance with study timelines, prevailing laws, Good Clinical Practices, and client standards
Initiate and coordinate start-up activities and essential document management toward high-quality Investigator Initiation Packages and site initiation approval
Resolve or escalate site issues and coordinate supporting roles for timely site activation
Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
Support Central Investigator Review Board packages and country-required committee submissions
Coordinate communications and responses between clients and central ethics committees
Support investigator sites through local IRB preparation, submission, and approval workflows
Prepare, handle, and distribute clinical documentation and reports
Support and implement Shared Investigator Platform activities aligned with client strategy
Manage essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
Maintain IRB/Ethics Committee activities
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 with audit and inspection responses
Maintain ongoing communication with study teams and investigator sites
Provide country- and site-level functional updates and establish tools for efficient status reporting
Disseminate ethics approvals and communicate local site approvals to stakeholders
Conduct site personnel awareness sessions as needed
Identify and resolve site issues and coordinate corrective and preventive actions
Serve as a Site Activation Partner point of contact or subject matter expert as assigned
Represent the SAP function on systems, processes, and global initiatives
Mentor new hires on processes and systems
Complete required training, timesheets, expense reports, and CV updates
Maintain knowledge of and comply with Parexel processes, ICH-GCP, and applicable requirements

Requirements

What you’ll need

At least 2 years of start-up experience and experience with US/CAN
Knowledge of clinical research and development processes and key operational elements of a clinical trial
Understanding of quality expectations and a right-first-time approach
Compliance with applicable 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 knowledge
Proficiency in computer operations
Ability to learn and independently use systems
Proficiency with Microsoft Suite
Experience with Clinical Trial Management Systems (CTMS)
Experience with electronic Trial Master File and electronic Investigator Site File systems (e.g. Florence)
Experience with document exchange portals, Shared Investigator Platform, and ethics, national networks, and governing bodies portals/platforms as needed
Flexibility to work off-hours in a global environment when applicable
Ability to travel as needed, including possible international travel
Experience working 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
Fluency in the local language and English required
Multilanguage capability preferred
For individuals based in Canada, bilingualism in French and English 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 relevant experience in clinical site management

Benefits

Comp & perks

7-month temporary assignment with the potential to transition into a full-time role
Full-time employment
Potential international travel