Site Start up Associate II

Premier Research Group; Northern (KY); Remote; USD 64,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU team. This remote, United States-based role supports biotech, medtech, and pharma clients in starting up sites for clinical trials.

You will manage regulatory submissions, site contracts, and informed consent documents across countries, ensuring adherence to ICH/GCP and sponsor requirements. The ideal candidate has 3+ years startup experience and a clinical/science background.

Qualifications

• Undergraduate degree in clinical/science/health related field.
• 3+ years direct site start-up experience.
• Strong knowledge of regulatory requirements (FDA/EU/ISO14155).

Responsibilities

• Forecasts submission/approval timelines and ensures adherence; provide contingency plans and escalate as needed.
• Prepare and submit EC/IRB, Local EC, RA submissions and other local approvals.
• Review essential documents to ensure sponsor and investigator requirements meet ICH/GCP guidelines.
• Negotiate site contracts and budgets with site and Contracts Lead until execution.
• Review and adapt informed consent templates and other patient documents per country requirements.

Skills

Startup experience

Regulatory knowledge

Informed consent documents

Education

Undergraduate degree in clinical/science/health

Job description

## Site Start up Associate IIApply: Remote: United States of America: Full time: Posted 11 Days Ago: R6649Premier Research is looking for a Site Start up Associate II to join our Clinical Monitoring, Site Management and SSU 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.**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 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.* 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.* 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.**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.* 3+ years' of direct study start up experience* Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.* Detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements* Proficient in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.* Ability to work independently with minimal supervision and complete work accurately, within quality expectations and agreed timelines.*Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $71,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.*