Site Start-Up Associate II or Sr
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Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Site Start-Up Associate II or Sr to join our team!
The Site Start-Up Associate performs all country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. This includes but is not limited to the following tasks: Liaise with the Site Recruitment Specialist, as applicable, to provide study start-up metrics and site contact information for the Investigator Database, coordinate with the Study Maintenance Associate to disseminate the Investigator Site File binders, essential document collection and review, tracking, site communications, Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, , protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up, customs clearance and import/export license management, transition all study start-up complete sites to the Study Maintenance Associate within timeline and in general all needed preparations for site activation. The current document describes all the activities and responsibilities for the Site Start-Up Associate position. However, because Site Start-Up is also a function within the project, this specific function may be delivered by employees with a different job title.
The Site Start-Up Associate:
- Takes responsibility for quality deliverables at the country level for site start-up in one or more components.
- Follows project requirements and applicable country rules.
- Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified
- Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. May provide regular updates of country specific information on the clinical trial application database on SharePoint. Submits end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.
- Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Prepares checklist for IP release according to country regulations.
- Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.
- Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
- Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
- Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
- Sets up and maintains a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
- Pending country in use, the SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.
- Provides quality review of the informed consent and adapts the template as appropriate.
- Works within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
- Ensures documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
- May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
- Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
- Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
- Mentors and trains junior level staff.
- Other activities as designated.