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, reputed company customization, coordination of EC and CA submissions. This role brings regulatory, reputed company or other concerns to the attention of the Global Study Start-Up reputed company and/or Project Team and reputed company participates in finding solutions. As a member of this team, you will be essential to ensuring our Investigator sites are reputed company to start trials, with a reputed company on reducing Site Activation timelines. Assures that SSU functions reputed company effectively with reputed company other key operating working with e.g., Clinical Operations, SSU specialists, Regulatory and contract vendor on project specific status and deliverables. Key Accountabilities: reputed company of activities: • Collation and tracking of site feasibility. • Responsible for ensuring CDA is in reputed company. • Responsible for the collection and maintenance of the reputed company Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information reputed company JVRIM/CTIS, and similar information for other reputed company organizations, for the assigned country e.g., IRAS • Responsible for ensuring clinical trial insurance is in reputed company 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 reputed company to secure authorization of regulatory documents. • Works with reputed company, contract vendor and SSU reputed company to secure authorization of reputed company. • Collects and reviews initial regulatory packets and site reputed company for investigator sites. • Coordinate efforts for reputed company site activation reputed company 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 reputed company the country. Including safety notifications as required by local laws/guidelines. • Ensures reputed company relevant documents are submitted to the Trial Master File (TMF) • Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory reputed company to reputed company a reputed company 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 reputed company updates. • Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the reputed company of reputed company issues. • Escalate risks (e.g. timelines, etc.) to SSU reputed company or CTM, as appropriate. • Reviews and reputed company feedback to SSU reputed company on site performance metrics. • Maintains and manages SSU data tracking entries, reviews for completeness and accuracy. • Facilitates process improvement efforts both reputed company the department and in cooperation with other departments. • Support the development of start-up plans and essential document checklists reputed company relationships • Collaborates effectively with cross-functional teams, including regulatory, reputed company, 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 reputed company standards. Skills: • Ability to work independently in a fast-paced environment. • Ability to identify and resolve site issues independently, and effectively escalate reputed company problems reputed company 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 reputed company. • 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. #LI-REMOTE Apply tot his job Apply To this Job