About this Senior Site Start up Associate role at Premier Research
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.
What You'll Be Doing:
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 ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules. Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines.
Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.
Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template. Submit proposed contract and budget to the site for review. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
What We Are Searching For:
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
5+ years of direct study start up experience
Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
Thorough knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements
Expertise in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.
An excellent team player with the ability to develop and maintain strong relationships across the organization to provide awareness of future issues and promote collaboration and problem-solving.
Strong verbal and written communication skills in English
