Study Start Up Specialist - US - FSP

The Junior Study Start-up Specialist is responsible for conducting and facilitating specific start-up activities that may include but is not limited to handling Confidentiality Agreements, processing feasibility questionnaire, essential document collection and review, ICF customization, coordination of EC and CA submissions. This role brings regulatory, timeline or other concerns to the attention of the Global Study Start-Up Lead and/or Project Team and actively participates in finding solutions. As a member of this team, you will be essential to ensuring our Investigator sites are prepared to start trials, with a focus on reducing Site Activation timelines. Assures that SSU functions interface effectively with all other key operating working with e.g., Clinical Operations, SSU specialists, Regulatory and contract vendor on project specific status and deliverables. Key Accountabilities: Oversight of activities:

• Collation and tracking of site feasibility.
• Responsible for ensuring CDA is in place.
• Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information for other related organizations, for the assigned country e.g., IRAS
• Responsible for ensuring clinical trial insurance is in place for submission.
• Responsible for the translation and co-ordination of translations for documents required for submission.
• Creation, review, and customization of country/site specific Informed Consent Forms (ICFs)
• Works with regulatory team members and SSU Lead to secure authorization of regulatory documents.
• Works with legal, contract vendor and SSU Lead to secure authorization of contracts.
• Collects and reviews initial regulatory packets and site contracts for investigator sites.
• Coordinate efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review, and approval of essential documents for IP Release
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, CA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines.
• Ensures all relevant documents are submitted to the Trial Master File (TMF)
• Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Attend project meetings with cross functional department leads to provide updates.
• Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
• Escalate risks (e.g. timelines, etc.) to SSU Lead or CTM, as appropriate.
• Reviews and provide feedback to SSU Lead on site performance metrics.
• Maintains and manages SSU data tracking entries, reviews for completeness and accuracy.
• Facilitates process improvement efforts both within the department and in cooperation with other departments.
• Support the development of start-up plans and essential document checklists

Collaborative relationships

• Collaborates effectively with cross-functional teams, including regulatory, legal, and clinical operations to manage site start-up activities, ensure compliance with regulatory requirements, and facilitate efficient clinical trial initiation that aligns with project timelines and quality standards.

Skills:

• Ability to work independently in a fast-paced environment.
• Ability to identify and resolve site issues independently, and effectively escalate complex problems when necessary, contributing to efficient risk management.
• Displays flexibility and willingness to support process improvement efforts, adapting to changing requirements and collaborating across departments to enhance overall efficiency.
• Excellent verbal and written communication skills, with the ability to effectively liaise with diverse stakeholders, including CRAs, CTMs, regulatory authorities, and cross-functional team members.

Knowledge and Experience:

• 3+ years Pharmaceutical or CRO industry experience
• Previous experience of working in a Start-up team, as a Clinical Trial Specialist, or similar role, having worked on global clinical trials.
• Experience of in-house trials/process design are beneficial
• Excellent knowledge of GCP and regulations

Education:

• Bachelor’s Degree or 3 years’ clinical research or other relevant experience; or equivalent combination of education, training, and experience.

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