Premier Research International

Contract research organization for clinical development

Senior Site Start-Up Associate

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRemote in ArgentinaNo salary listedRemote

About the Job

Requirements

An undergraduate degree or its international equivalent in a clinical, science, or health-related field from an accredited institution, or status as a licensed healthcare professional.
At least five years of direct study start-up experience.
Thorough knowledge of FDA guidance documents, EU directives and regulations, local regulations, ISO 14155 regulations, drug and 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 developing and reviewing informed consent form templates, other patient documents, or specific documentation required in the country.
Strong verbal and written communication skills in English.

Responsibilities

Forecast submission and approval timelines and ensure they are met; provide rationale and contingency plans for delays and escalate issues when identified.
Serve as a primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager, or designee during start-up on allocated projects, as applicable.
Prepare ongoing submissions and amendments required by central and local ethics committees or institutional review boards under local rules.
Submit end-of-study notifications to ethics committees, institutional review boards, and other local authorities according to national timelines.
Perform or oversee essential document collection and review, ensuring sponsor and investigator obligations are met and comply with local regulatory requirements and ICH/GCP guidelines.
Negotiate local investigator contracts and budgets where applicable, produce site-specific contracts from the country template, submit proposed contracts and budgets to sites for review, and work with sites and the Contracts Lead and sponsor to resolve issues and execute contracts.
Quality-review informed consent documents and adapt templates and other patient documents or country-required documentation as appropriate.
Support preparation of project-specific start-up strategies at the proposal stage to support business development opportunities, as applicable.

Desired Qualifications

Ability to develop and maintain strong relationships across the organization to raise awareness of future issues and promote collaboration and problem-solving.

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

About the Company

Premier Research International

Contract research organization for clinical development

Premier Research provides specialized clinical development services for biotech and specialty pharma, focusing on the therapeutic areas where leading scientists work. It supports end-to-end clinical trials including design, site management, data management, biostatistics, regulatory affairs, and medical writing across 20+ countries with about 1,500 employees. It differentiates itself with deep expertise in select therapeutic areas, strong execution, global reach, close collaboration, patient impact, and flexible working conditions. Its goal is to help biotech and pharma teams bring safe, effective therapies to patients faster through high-quality development and regulatory support.

Company size: 1,001-5,000
Company stage: Acquired
Total funding: $79.2M
Headquarters: Morrisville, NC
Founded: 1989

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