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.
We’re looking for a talented and energetic Clinical Research Associate II or Senior CRA to join our team in France!
Working at Premier Research means being an individual - you will be recognized 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!
What you’ll be doing:
- Deliver quality, timely monitoring reports for Sponsor approval per the Clinical Monitoring Plan timelines
- Maintain submission of expenses according to travel and expense requirements within company guidelines
- Hold responsibility 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
- Monitor (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Prepare for and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
- Monitor with knowledge of quality/scope/timeline and budget parameters
- Cooperate with the Clinical Manager to enhance and proactively manage site visits and trial issues during the monitoring phase
- Manage query resolution process with sites and Premier Research Data Management
- Maintain Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Reviews site documents and verifies they are accurate, complete, current, and include required updates
- Assist project team with assessing project feasibility and recruitment, as applicable
- Maintain project tracking system of subjects and site information, as applicable
- Participate in Investigators’ Meeting as designated by the Project Manager
- Ensure site visit metrics and utilization are maintained as required
- Complete timely entry of hours worked and project codes per time entry guidelines
- Review of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring Plan
- Maintain proper, timely communication with sites, study teams and management.
- 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/mentor for other CRAs and shares knowledge base and best practices.
You'll need this background to be considered:
- 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
- Grounded experience in monitoring complex Oncology trials or global trials or equivalent experience
- At least 4 years’ experience in clinical trials
- Experience in coaching/mentoring other CRAs
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations /
- ISO14155 regulations, drug / device development, and clinical monitoring
- Fluent verbal and written English; fluent in host country language
- Excellent organizational and time-management skills, able to meet deadlines
- Customer service focused in approach to work, both internally and externally
- Maintains a positive, results orientated work environment
- Travel: 70-85%