Senior Site Start up Associate

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

• Takes responsibility for quality deliverables at the country level for study start-up; follows project requirements and applicable country rules.
• Forecasts submission/approval timelines and ensures they are adhered to. Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (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. Assists with EC/IRB or CA issue resolution at the country level.
• Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules. Submits end of study notifications to RA, ECs/IRBs and other local authorities in the specified country according to national timelines.
• Performs essential document collection and review, ensuring that sponsor· Ensures documentation of QC of eTMF within the scope of File Management Plan (FMP) 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.
• 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.

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
• Proven experience as a SSUA Level 2 and/or 7+ years relevant experience, including at least 5 years’ experience as a SSUA or in the submission of clinical trial applications.
• Broad experience working on different study types/phases such as interventional IMP studies, non-interventional studies, medical Device studies, GMO studies, and observational studies.
• Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
• Expertise in ICH/GCP and/or ISO14155 and local regulatory authority drug research and development regulations.
• Thorough knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements
• Thorough knowledge of web-based communication tools for conferences and any other IT systems required for the job.
• Thorough 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.
• Expertise in the development and review of Informed Consent Form templates, other patient documents, or specific documentation required in the country.
• Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template. 
• Submit proposed contract and budget to the site for reviews. 
• Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status