Senior Clinical Research Associate / Clinical Research Associate II

Premier Research Group; United States; Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Premier Research is seeking a Senior Clinical Research Associate / CRA II to join the Clinical Monitoring, Site Management and SSU team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

We value growth, flexibility, and a voice that matters as we deliver medical innovation to patients. Join us to deliver high-quality monitoring reports, manage site visits, and maintain TMF/eTMF in compliance with ICH/GCP.

Qualifikationen

• Undergraduate degree in clinical, science, or health-related field, or equivalent work experience.

Aufgaben

• Delivers quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
• Maintains submission of expenses according to travel and expense requirements within company guidelines.
• Monitors (remote, onsite or other approved mode) with a focus on data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out visits.
• Maintains Trial Master File (TMF)/eTMF per filing guidelines and verifies essential documents per ICH/GCP.

Ausbildung

Undergraduate degree (clinical, science, or health-related field)

Licensed health-care professional

Jobbeschreibung

Premier Research is looking for a Senior Clinical Research Associate / Clinical Research 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:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines

• Maintains submission of expenses according to travel and expense requirements within company guidelines

• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations

• Plans day to day activities for monitoring of a clinical study and sets priorities per site

• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan

• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verify they are accurate, complete, current, and include required updates

What we are searching for:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required

• Previous clinical research experience required, completion of CRA training program

• At least 4+ years’ experience in clinical trials to qualify for a Senior CRA level and at least 2+ years’ experience in clinical trials to qualify for a CRA II level.

• The required CRA certification, qualifications and training record as per the requirements of the Italian Decree.