Senior Site Start-Up Associate
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Senior Site Start-Up Associate to join our team in Italy!
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
- 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.
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
- Previous experience in the submission of clinical trial applications. Clinical monitoring experience is preferred in specific countries
- Prior experience using computerized information systems preferred
- Ability to read, write, and speak fluent English; fluent in host country language
- Office based or clinical employment experience preferred
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Knowledge of site and institution specific contract requirements
- Clinical trials support or pharmaceutical industry experience required
- Works with internal and external customers/vendors to meet project specific goals
- Identifies, monitors, documents, and tracks out-of-scope activities
- Proficient in the development and review of Informed Consent Form templates
- May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents
- Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions
- Assists with mentoring and training staff
- Manages time and project requirements based on study contract
- 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
- Provides data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the CDA/contract template
- Provides input in local SOPs and WG
- Support for the creation of internal training materials on for local legislation requirements
- Provides input to the team to assist with EC or CA issue resolution at the country level
- Possible Travel 10%
- Same Accountabilities as Level 2
- Thorough knowledge of ICH/GCP and/or ISO14155 and local regulatory authority drug research and development regulations required
- Serves as primary liaison for site start-up and site start-up management issues, escalating to CM and/or PM as required
- Ensures that all site start-up tasks meet expectations and are delivered in accordance with the contracted time lines
- Leads larger programs through start-up
- Possible Travel 10%
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication and negotiation skills
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Is customer-service focused in approach to work, both internally and externally
- Maintains a positive, results orientated work environment