The Study Start-up Specialist (SSUS), contract position –is responsible for all Study start-up related activities Roche Ukraine clinical trials department
Main Responsibilities and Accountabilities:
• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
• Executes assigned start-up activities prior to site activation on assigned.
• Obtains regulatory Clinical Trial Application package and relevant site documents, prepares required translations, collates submission files ensuring quality and compliance with local regulations, submits to RA/LECs, supports communication with RA and obtains RA opinion. Uploads/stores documents as required. Up-dates relevant systems and tracking-tools.
• Prepares country level Informed Consent Form (ICF). Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
• Supports drug label preparation and approval
Qualifications and Competencies:
University Degree or equivalent, preferably in a medical/science-related field. Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in Ukraine.
Availability to travel domestically and internationally if required.
Ability to communicate clearly and accurately in both written and spoken: Ukrainian, Russian and English
Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork
Able to make effective decisions, self-motivated, assertive, and displays initiative
Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.