Site Partner II coordinating site activations and maintaining communication with stakeholders for clinical studies. Responsible for ensuring timely approval and quality of site documentation.
Responsibilities
Accountable for the proficient and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across multiple studies.
Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience.
Ensure Critical Document Package (CDPs) and Site Activation approval dates are forecasted and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur.
Collect and collate site CDPs for review and approval prior to site activation in accordance with all requirements, while ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the Trial Master File.
Ensure timely submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements.
Prepare, collect and collate all requirements for site CDPs for review and approval prior to site activation in accordance with ICON SOPs/WPs, Sponsor requirements, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF.
Serve as internal expert consultant in regards to assigned key Institutions and sites to build relationships and internal data repository.
Requirements
Bachelor's Degree
0-3 years of experience in a Clinical Research environment
Good communication skills
Good Judgment & Decision Making
Proficient computer knowledge.
Proficiency in English language is mandatory
Knowledge of basic French is preferred
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize 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.
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