Site Start up Associate I

Premier Research•Regional_NC, NC

2d•$60,000

About The Position

Premier Research is looking for a Site Start up Associate I to join our Regulatory Submissions and Contracts team. 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.

Requirements

Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional.
1 – 2 years of related experience in a health sciences or biology area.
Ability to manage several tasks and work effectively in a fast-paced environment with changing priorities.
Ability to work accurately, within quality expectations and agreed timelines.
Ability to interpret the relevant directives and guidelines.

Nice To Haves

Clinical trials support or pharmaceutical industry experience preferred.

Responsibilities

Performs essential document collection and review, ensuring that sponsor and investigator requirements 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. Submits 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.
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.
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.
Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.