Site Start Up Associate Ii
3 days ago
At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a
**Site Startup Associate II** to join our
**Study Startup**
***team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
The position can be offered as
**office based.**
**What you’ll be doing**
- Takes responsibility for quality deliverables at the country level for study start-up.
- 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.
- May serve as the primary point of contact for the Project Manager, Clinical Manager,
- 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.
- 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.
**What we are searching for**:
- Successful experience and results at SSUA Level 1.
- Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
**Why choose Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
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