Site Start up Associate II
Premier Research
Summary
Premier Research is looking for a Site Start up Associate II to join our Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
Job description
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.
Requirements
- Undergraduate degree or international equivalent in a clinical, science, or health related field from an accredited institution or 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 relevant country specific regulatory requirements for conducting clinical trials and site and institution specific contract requirements
- Proficient in development and review of Informed Consent Form templates, other patient documents, or specific documentation required in the country
- Ability to work independently with minimal supervision and complete work accurately within quality expectations and agreed timelines
Benefits
- Health Insurance
- Retirement Plans
- Paid Time Off
Company overview
Premier Research International LLC is a global leader in clinical research and consulting services dedicated to helping biotech, specialty pharmaceutical, and medical device innovators transform breakthrough science into life-changing therapies. Founded in 1989, the company specializes in addressing trial complexity, overcoming development hurdles, and demonstrating product value through integrated end-to-end solutions. With deep therapeutic expertise across oncology, hematology, immunology, rare diseases, cell and gene therapy, and women's health, Premier Research leverages innovative technology and operational proficiency to deliver accelerated development timelines. The company operates globally with over 2,000 employees across more than 70 countries, managing clinical trials from preclinical planning through commercialization. Premier Research's mission focuses on turning brilliant ideas into new medical treatments by providing personalized clinical research, product development, and consulting services that help answer unmet patient needs across a broad range of medical conditions.