Life Science People are a strategic growth partner within the Life Science industry, providing bespoke services to the life science community from SMEs through to blue-chip organisations and sourcing the best talent to make a tangible contribution to healthcare.
Do you want to become part of a team dedicated to supporting the development of ground-breaking drugs and devices and provide hope for those living with debilitating diseases? Are you based in France, happy to work from home and looking to take that next step in your career? If so, this may be the role for you...
As a Home-based Experienced Clinical Research Associate (CRA) you will have the following responsibilities:
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Conduction of qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
- Communication with the medical site staff.
- Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
- Regulatory document review
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
- Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement
The company has a full-service approach which is led by medical, regulatory and operational experts with deep therapeutic experience. The disciplined processes and technologies enable CTMs to execute even the most complex global studies. Therapeutic focus areas including oncology, cardiovascular, endocrine/metabolic, infectious disease, CNS. Trials include those in rare disease and Advanced Therapies.
- Experience as a Clinical Research Associate, minimum 2 years.
- Approximately 60-80% non-local, national travel is required.
- Must have a minimum of a bachelor's degree in a health or science related field, preferably a master's degree.
- Proficient knowledge of Microsoft® Office
- Fluency in English and French
- Outstanding communication skill
- Must be detail-oriented and efficient in time management.
- Must be based in France
THEY OFFER THE FOLLOWING:
- Customized CRA training program based on your experience and therapeutic background and interest
- User friendly CTMS with electronic submission and approval of monitoring visit reports
- Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts
- National assignments with a very large pipeline of projects possibility
- In-house CTA administrative support for all levels of CRAs
- Close collaboration with CRA manager
- Opportunities to work with international project team
- Competitive travel bonus
- No metric for minimum required days on site per month
- Home office furniture allowance, mobile phone and hotspot for internet access anywhere
- For Home office CRA : monthly allowance in addition to the salary
- In-house travel agents and Per Diem allowance for all day on site
- Opportunity for transversal activity like CRA lead positions, mentoring, CRA evaluator, super users, SME role.
- Low turnover rates for CRAs
If this role interests you, then please apply now. We will send you a confirmation of acknowledgement, and please note feedback can take up to 2-3 weeks. Upon successful selection for an interview, the process will occur in the following three stages:
First stage: This will be an initial screening call with a Life Science People representative
Second stage: An initial phone call with the hiring manager - Managing Director to go through background and experience in relation to the role.
Final Stage: This will be a final interview with key stakeholders within the business.
The Clinical Trial Manager role is a full-time permanent position, paying up a competitive salary & benefits package. The role is based in France and home-based. Full details will be provided on application.