Study Start Up Associate I

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
• Register investigator sites and Company stakeholders in Company registries and systems as required.Update and regularly maintain the registry with accuracy and have it inspection ready.
• Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.
• Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, for internal regulatory approval within required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.
• Coordinate the timely communication, documentation and responses between Company and Central Ethics committee to bring clinical study to approval (country dependent).
• Support investigators sites with local IRB workflow from preparation, submission through approval.
• Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed.
• Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to SIV.
• Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Support & implement activities in Shared Investigator Platform to align with Company strategy as it relates to the role.
• Coordinate translation of documents that are within scope with the preferred translation vendors.

• Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, Ethics Committee annual approvals and other activities required during study conduct.
• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable.
• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections.

• BS/BA or bachelor’s degree in life sciences preferred
• Minimum 2 years relevant experience in clinical site management.
• Experience working in the pharmaceutical industry/or CRO in study site activation is an asset.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.
• Home-Based

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

ICON