Clinical Research Associate II / Sr. CRA (Medical Device), Germany
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
We’re looking for a talented and energetic CRA II / SCRA with Medical Device experience in Germany to join our team.
This is a permanent role and we are open to this role being located either in our office in Darmstadt or home based in Germany.
Imagine. Inspire. Innovate. Impact. With Us.
You’ll be accountable for:
- Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Scheduling site visits for monitoring as required by protocol monitoring visit windows.
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
- Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information.
- Participating in Investigators’ Meetings as assigned by Project Managers.
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
- Mentoring junior-level staff and sharing knowledge and best practices.
- Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
- In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
- Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
- 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.
- Prior experience in monitoring of medical device trials (Cardiovascular .experience is preferred but not mandatory)
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication skills
- Fluency in written and verbal German and English is mandatory. Any other language is a bonus.
- Excellent organizational and time-management skills, able to meet deadlines
- Self-starter with lots of common sense and able to act on own initiative
- Accountable, dependable and strong commitment
- Applies clear and consistent performance standards and handles problems decisively and objectively
- Customer service focused in approach to work, both internally and externally
- Maintains a positive, results orientated work environment
- Travel: 60 - 70%
- Willing to monitor throughout Europe, as required
- Valid driver’s license, passport as required