Site Activation Partner I

This is a fully remote position, open to applicants in Australia.

📋 Description

• Initiate and manage clinical trial site activation activities along with essential document oversight.

• Compile comprehensive Investigator Initiation Packages that lead to site initiation approval.

• Address or escalate site-related issues while coordinating supporting roles to ensure timely activation.

• Prepare, verify, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms.

• Assist with Central Investigator Review Board packages and submissions in accordance with country regulations.

• Facilitate communication, documentation, and responses between clients and ethics committees.

• Aid investigator sites with local IRB workflows from preparation and submission to approval.

• Prepare, manage, and distribute clinical documentation and reports in line with scope and SOPs.

• Support Shared Investigator Platform activities that align with client strategies.

• Coordinate essential documents and updates throughout the study lifecycle, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals.

• Oversee IRB/Ethics Committee activities.

• File documents in the Trial Master File and assist with periodic quality reviews.

• Update and maintain clinical trial systems that track site compliance and performance.

• Assist investigator sites and study teams with responses to audits and inspections.

• Maintain communication with study teams and investigator sites, providing updates at the country and site level.

• Create tools for efficient tracking of site status, issues, delays, and approvals.

• Distribute ethics approvals and communicate local site approvals to study teams and stakeholders.

• Conduct awareness sessions with site personnel regarding client requirements and documentation compliance as necessary.

• Identify and resolve issues at investigator sites, coordinating corrective and preventative actions.

• Act as a point of contact, subject matter expert, or representative for the Site Activation Partner on global initiatives as assigned.

• Provide mentorship to new hires on processes and systems.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Stay informed about and comply with Parexel processes, ICH-GCP, and relevant requirements.

⛳️ Requirements

• Understanding of clinical research and development processes, along with key operational elements of a clinical trial.

• Knowledge of quality expectations and principles of right-first-time.

• Adherence to applicable company policies, regulatory standards, and country-specific requirements.

• Strong attention to detail and a disciplined approach to work.

• Ability to operate independently as well as collaboratively within a team.

• Skill in organizing tasks, time, and priorities while managing multiple tasks.

• Basic understanding of medical terminology and GCP requirements.

• Proficient in computer operations.

• Capability to independently use and learn various systems.

• Experience with Microsoft Suite.

• Familiarity with Clinical Trial Management Systems (CTMS).

• Experience with electronic Trial Master File (TMF) systems.

• Knowledge of electronic Investigator Site File systems, such as Florence.

• Proficiency in using document exchange portals.

• Experience with Shared Investigator Platform.

• Familiarity with ethics, national networks, and governing bodies' portals and platforms as required.

• Willingness to work off-hours in a global environment when necessary.

• Ability to travel as required, including potential international travel.

• Preferably have experience in the pharmaceutical industry or CRO related to study site activation.

• Knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and global and local country regulations.

• Fluency in the local language and English is mandatory.

• Multilanguage capability is a plus.

• Strong verbal and written communication skills.

• Good technical skills with the ability to learn and operate multiple systems.

• A school diploma or certificate with an equivalent combination of education, training, and experience, or a Bachelor of Science/Bachelor of Arts or equivalent degree.

• Minimum of 2 years of relevant experience in clinical site management.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company match.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Collaborative and inclusive work environment.