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
Skills Required
- Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution, or licensed healthcare professional
- 3 or more years of direct clinical study start-up experience
- Working knowledge of FDA Guidance Documents, EU Directives and Regulations, local regulations, ISO 14155, drug and device development, and clinical monitoring procedures
- Detailed knowledge of country-specific regulatory requirements for clinical trials and site or institution-specific contract requirements
- Proficiency developing and reviewing informed consent form templates, patient documents, and country-required documentation
- Ability to work independently with minimal supervision and complete work accurately within quality expectations and agreed timelines
What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
