Clinical Research Associate

11 Premier Research International LLC; Pennsylvania; On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Clinical Research Associate II to join our Northeast US team. The CRA II will monitor Phase I–IV trials and device studies, both on-site and remotely, ensuring data integrity and patient safety in compliance with ICH-GCP/ISO requirements.

You will interact with investigative sites, vendors, and clients while managing study timelines and budgets. Password-protected details include travel of 70-85% and a base pay around market standards.

Qualifications

• Undergraduate degree required or international equivalent.
• Minimum of 18+ months on-site clinical research monitoring experience.

Responsibilities

• Perform monitoring activities (on-site and remote) for Phase I–IV trials and device studies.
• Serve as primary contact for investigative sites and manage query resolution.
• Ensure data validity, accuracy, and timeliness in line with trial protocol and GCP/ISO requirements.
• Identify risks and provide retraining opportunities for sites.
• Plan and schedule day-to-day monitoring visits and complete high-quality trip reports.

Skills

On-site monitoring

Customer focus

Communication skills

Education

Undergraduate degree

Job description

Premier Research is looking for a Clinical Research Associate II- Northeast US 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. 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.

The Clinical Research Associate II (CRA II) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. This role performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA II proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.

What you’ll be doing:

• Perform monitoring activities (both on site and remote) including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, Close Out Visits for Phase I-IV clinical trials, as well as device trials with opportunities to work in the following Therapeutic areas: oncology, pediatrics, rare disease.
• Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
• Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget.
• Identify and elevate potential risks and possible retraining opportunities for investigative sites.
• Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high quality trip reports, and active management of all deliverables.

What we are searching for:

• Undergraduate degree required or its international equivalent
• Minimum of 18+ months previous on‑site clinical research monitoring experience required
• Known for being customer‑focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas
• Experience with monitoring oncology/neurology/rare disease/dermatology studies are preferred
• Accountable, dependable and strong commitment
• Ability to meet the requirement of 8‑10 DOS (Days on site)/monitoring visits/month
• 70‑85% travel
• Valid driver’s license, passport as required

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $80,000 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.

• Health insurance
• Retirement plans
• 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.

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.