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Senior CRA, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast)

Role overview

Qualifications

  • Undergraduate degree or its international equivalent
  • Minimum of 4+ years previous on-site clinical research monitoring experience
  • Experience with monitoring oncology/neurology/rare disease/dermatology studies
  • Valid driver’s license, passport as required

Responsibilities

  • Perform monitoring activities including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Site Management Contacts, and Close Out Visits for Phase I-IV clinical trials
  • Ensure the validity, correctness, and completeness of clinical data collected at sites
  • Serve as the primary point of contact for investigative sites, manage query resolution, and support Trial Master File activities
  • Schedule and plan day-to-day activities including study monitoring visits and active management of all deliverables

Key facts

  • Remote from: United States
  • Full time
  • Senior (5-10 years)
  • 105 - 105K yearly
  • English

Other skills

  • Communication
  • Accountability
  • Reliability

About the company

Premier Research logo

Premier Research

Biotechnology

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management. Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results. As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. 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!

Company details

Company typeLarge
IndustryBiotechnology
Company size1001 - 5000

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Job description

Premier Research is looking for a Senior CRA, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast) 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:

  • 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 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.

What we are searching for:

  • Undergraduate degree required or its international equivalent, along with minimum of 4+ years 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 required

  • Accountable, dependable and strong commitment 

  • Ability to meet the requirement of 8-10 DOS (Days on site)/monitoring visits/month; 70-85% travel

  • You must live in the West Coast, North East, or Midwest Regions

  • Valid driver’s license, passport as required

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $105,000.00 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

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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