Site Start Up Associate I

5 months ago

Remote, India Premier Research Full time

Premier Research is looking for a Site Start Up Associate 1 to join the SSU Team in India. 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 Built for You. 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.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for BiotechSM. Join us and build your future here.

**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.
- Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Prepares Investigational Product (IP) checklist according to country regulations.
- Ensures accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.

**What We Are Searching For**:

- Provides all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct.
- Collects information on submission deadlines and timeline metrics for RAs, ECs, IRBs 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.
- Sets up and maintains a country folder with country ECs/IRBs and local authority addresses and requirements, as required.
- 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.
- Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study
- Enters and maintains trial status information relating to SSU activities into Premier’s tracking databases, in an accurate and timely manner.
- 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.
- Performs other duties as required

**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 Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, 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.
- Diversity, Equity, and Inclusion Statement - all global roles must include the following

Because we are transforming life-changing ideas into new medical

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