Clinical Research Associate - Home-Based in the Netherlands
- Experience Level
- Experienced (non-manager)
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Clinical Research Associate to bring your passion to our team. This position is part-time (80%) and home-based in the Netherlands.
You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
- 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
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plans
- Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
- Manages query resolution process with sites and Premier Research Data Management
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.
- Assists project team with assessing project feasibility and recruitment, as applicable
- Participates in Investigators’ Meeting as designated by the Project Manager
- Ensures site visit metrics and utilization are maintained as required and escalates available time as necessary to line manager
- Participates in available training offered to increase therapeutic knowledge
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- In specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc. This will be documented with the appropriate guidance or functional description
- In specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g. Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional lead
- Acts as a resource for other CRAs and shares knowledge base and best practices.
- 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
- Min. 1 year of clinical monitoring experience, completion of CRA training program
- Fluency in English and in host country language
- At least 2+ years’ experience in clinical trials
- Global experience preferred
- Knowledge of ICH / GCP regulations
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices
- Excellent team player, collaborative and able to enable an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication skills
- Excellent organizational and time-management skills, able to meet deadlines
- Maintains a positive, results orientated work environment
- Travel: 40-50%
- Valid driver’s license, passport as required