Site Activation Partner I
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Job Description
Site Activation Partner coordinating regulatory documents, ethics approvals, and investigator-site activities for Parexel, a global clinical research organization. Supporting clinical trials from startup through study conduct and compliance.
Responsibilities:
- Initiate and coordinate clinical trial site activation activities and essential document management through Investigator Initiation Package compilation and site initiation approval
- Prepare, validate, and submit regulatory documents and support internal regulatory approval
- Coordinate supporting roles, ethics committee submissions, investigator site workflows, and study approval activities
- Manage clinical documentation, reports, and Shared Investigator Platform activities
- Coordinate study-conduct documentation and updates, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee approvals
- Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
- Perform periodic quality reviews of study files for accuracy and completeness
- Update clinical trial systems tracking site compliance and performance
- Support investigator sites and study teams with audit and inspection responses
- Maintain communication with study teams, investigator sites, clients, and stakeholders
- Provide country- and site-level updates on site status, issues, delays, and approvals
- Support site personnel awareness sessions and ongoing compliance with study documentation, applicable laws, GCP, and client standards
- Identify and resolve investigator site issues and coordinate corrective and preventative actions
- Serve as a Site Activation Partner point of contact, subject matter expert, or representative on initiatives as assigned
- Support mentoring of new hires on processes and systems
- Complete required training, timesheets, expense reports, and CV updates
- Comply with Parexel processes, ICH-GCPs, and other applicable requirements
Requirements:
- Knowledge of clinical research and development processes and key operational elements of clinical trials
- Ability to understand process details and quality expectations
- Compliance with applicable company, regulatory, and country requirements
- Strong 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
- Knowledge of Good Clinical Practice (GCP) requirements
- Proficient in computer operations and able to learn and independently use multiple systems
- Experience with Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics/governing-body portals as needed
- Flexibility to work outside standard hours in a global environment when applicable
- Able to travel as needed, including possible international travel
- Experience in pharmaceutical industry or CRO 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; multilingual 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
- Life sciences education preferred
- Minimum 2 years of relevant experience in clinical site management
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