Clinical Research Associate II

Premier Research International; España; Hybrid; EUR 42,000 - 68,000; Full time

Job summary

Premier Research International in Madrid is seeking a Clinical Research Associate II to join our Clinical Monitoring team. You will deliver quality monitoring reports, manage TMF/eTMF, and ensure data integrity across dermatology trials in I-IV phases.

The role offers remote/hybrid/office options from Madrid, with approximately six days on-site per month and country-wide monitoring requirements. A healthcare-related undergraduate degree with 2+ years in clinical trials is expected.

Qualifications

• Undergraduate degree in a clinical, science, or health-related field or equivalent work experience.
• Previous clinical research experience required.
• At least 2+ years' experience in clinical trials and independent monitoring.
• Experience working in Dermatology therapy area preferred.

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 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 the clinical monitoring plan.
• Maintains TMF/eTMF as defined by the organization's processes per filing guidelines.

Skills

Clinical monitoring

Data integrity

Regulatory compliance

Dermatology experience

Education

Undergraduate degree in clinical, science, or health-related field

Job description

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. 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. 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

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
• 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.