Clinical Research Associate II

Premier Research is looking for a 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.

About Premier Research

• 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.

Responsibilities

• 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.
• Understands the required essential documents according to ICH/GCP Section 8.
• Reviews site documents and verifies they are accurate, complete, current, and include required updates

Requirements

• 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
• At least 2+ years’ experience in clinical trials and independent monitoring

Experience working in Dermatology therapy area required

• Preference at working across all phases I-IV, although phase II and III only will be considered
• The role can be offered as fully remote, hybrid or office based, from Madrid.
• There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.