[Hiring] Clinical Research Associate II @Premier Research

Role Description

Premier Research is looking for a Clinical Research Associate II - FS to join our Functional Services Provider (FSP) 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:

• 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.
• 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 escalate 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.

Qualifications

• Undergraduate degree required or its international equivalent.
• Minimum of 2+ years previous clinical research monitoring experience required.
• Known for being customer-focused in approach to work and communications.
• Ability to professionally interact with sites, clients, vendors, and other functional areas.
• Experience with monitoring oncology studies highly prioritized.
• Accountable, dependable, and strong commitment.
• Ability to meet the requirement of 8 DOS (Days on site)/monitoring visits/month; 70-85% travel.
• Preferred Location: East Coast.

Requirements

• This is a 12 month 1099 contractor position that will start off part-time with potential to go full-time.

Benefits

• Premier Research is dedicated to providing compensation that is fair and competitive with market standards.
• 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.
• 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.