Clinical Research Associate II
il y a 1 semaine
We are seeking a highly skilled Clinical Research Associate II to join our team in Marseille, France. As a key member of our clinical team, you will be responsible for conducting clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
Key Responsibilities:- Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Gain an in-depth understanding of the study protocol and related procedures.
- Perform remote and on-site monitoring & oversight activities.
- Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Support and/or lead audit/inspection activities as needed.
- Manages and maintains information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
- Ability to travel domestically and internationally approximately 65%-75% of working time. Expected traveling ~2-3 days/week.
- Min. 2 years of direct site monitoring experience in a bio/pharma./CRO.
- Master Degree in Sciences or Biology or Clinical Research.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyze data/metrics and act appropriately.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
- Fluent in French and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Competitive remuneration package with excellent benefits.
- Commitment to your development and training, with the opportunity to progress your career within a market-leading and innovative organization.
- Opportunity to work within a successful and rewarding environment.
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