Site Start-Up Specialist II: Regulatory Submissions

11 Premier Research International LLC; North Carolina; On-site; USD 64,000 - 78,000; Full time

Job summary

Premier Research is seeking a Site Start up Associate II to join its Clinical Monitoring, Site Management and SSU team in the United States. The role focuses on start-up activities for biotech, medtech and specialty pharma projects, including regulatory submissions and site documents.

The ideal candidate has a clinical/science/health background, 3+ years in study start-up, and strong knowledge of global regulatory requirements.

Qualifications

• 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.

Responsibilities

• 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.

Education

Undergrad degree

Job description

Premier Research is seeking a Site Start up Associate II to join its Clinical Monitoring, Site Management and SSU team in the United States. The role focuses on start-up activities for biotech, medtech and specialty pharma projects, including regulatory submissions and site documents.

The ideal candidate has a clinical/science/health background, 3+ years in study start-up, and strong knowledge of global regulatory requirements.