Clinical Research Associate II (Neurology, Oncology, Rare Disease, Pediatrics)

43 Premier Research Germany Ltd; Deutschland; Hybrid; EUR 60.000 - 75.000; Vollzeit

Zusammenfassung

Premier Research is seeking a Clinical Research Associate II in Germany to support neurology, oncology, rare disease and pediatrics trials. You will work across site monitoring, data quality and patient safety, collaborating with sponsor teams to advance innovative medicines and devices.

The role involves on-site and remote monitoring, TMF/eTMF upkeep, and planning visits. Candidates should have 4+ years in trials, an appropriate clinical degree or licensed healthcare background, and be prepared

Qualifikationen

• Undergraduate degree in clinical, science, or health-related field or licensed health-care professional.
• Previous clinical research experience.
• 4+ years’ experience in clinical trials and independent monitoring.
• Experience across therapy areas: Neurology, Oncology, Rare Disease, Pediatrics.
• Phase I–IV experience preferred (II/III acceptable).
• Willingness for country-wide monitoring; ~6 days on site per month.
• Must be located in Germany.

Aufgaben

• 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) with focus on data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring of a clinical study and sets site priorities.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out visits as required by the monitoring plan.
• Maintains TMF/eTMF per filing guidelines and understands essential documents per ICH/GCP.
• Reviews site documents and verifies they are accurate, complete, current, and updated.

Kenntnisse

Clinical monitoring

TMF/eTMF management

Data integrity

Patient safety

Ausbildung

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

Jobbeschreibung

Premier Research is looking for a Clinical Research Associate II (Neurology, Oncology, Rare Disease, Pediatrics) 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 4+ years’ experience in clinical trials and independent monitoring
• Experience working ideally across all, if not some, of the following therapy areas; Neurology, Oncology, Rare Disease and Pediatrics
• Preference at working across all phases I-IV, although phase II and III only will be considered
• There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.
• You must be located in Germany to be considered for this position.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need.

We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.