* The Clinical Operations Hub Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/hub, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.
Main Responsibilities and Accountabilities
* Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
* Executes all start-up activities prior to site activation on assigned studies, according to Roche standards and aligned with study/project requirements and timelines.
* Prepares country and/or site Informed Consent Form (ICF) and clinical study documents which need translation from English into local language.
* Obtains ethics committees’ and local regulatory authorities’ approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country. Update the relevant systems as required for tracking of the local IRBs/IECs and regulatory authorities activities .
* Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.
* Partners with Clinical Study Managers (CSMs) and Clinical Study Specialists (CSSs) to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.
* Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
* Submits, where applicable and according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs) in collaboration with LSR.
* In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.
* Participate in study budget process and is responsible for contracts negotiation in collaboration with Business Support Leader and Country Study Manager, as required and ensures compliance with Fair Market Value (FMV) in the country.
* Attend / complete all requisite on-line and F2F trainings (Role specific, Safety responsibility and Compliance) within specified time limit
* Identify, collect and immediately report all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations
Adhere to company (both local and global) policies and procedures at all times, including Health & Safety requirements.
University Degree or equivalent, preferably in a medical/science-related field.
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