Site Start up Associate II

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 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.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.