Senior Site Start up Associate

Premier Research Group; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Premier Research seeks a Senior Site Start Up Associate to join our Clinical Monitoring, Site Management and SSU team. You will coordinate regulatory submissions, site contracts, and essential documents while ensuring compliance with FDA guidance and local regulations.

You will work with biotech, medtech and pharma clients to drive timely start-up milestones, building strong internal and external relationships and supporting business development opportunities.

Qualifications

• Undergraduate degree in a clinical, science, or health field.
• 5+ years of direct study start up experience.
• Thorough knowledge of FDA Guidance Documents and local regulations.
• Knowledge of country-specific regulatory requirements for clinical trials.
• Experience developing and reviewing Informed Consent Forms and patient documents.
• Strong team player with excellent English communication and collaboration skills.

Responsibilities

• Forecast and manage start-up timelines, escalate delays with contingency plans.
• Prepare submissions to central/local EC/IRBs and notify authorities per timelines.
• Oversee document collection to ensure sponsor and investigator obligations are met.
• Negotiate site contracts and budgets with sites and Contracts Lead.
• Review informed consent templates and patient documents for country requirements.
• Contribute to start-up strategy for projects at the proposal stage.

Skills

Regulatory coordination

English communication

Cross-functional collaboration

Contract & budget awareness

Attention to timelines

Education

Bachelor's degree in clinical/science/health

Job description

Premier Research is looking for a Senior Site Start up Associate 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 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 countrytemplate.Submitproposed contract and budget to the site forreview.Negotiatesbudget 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 / EUDirectives/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