Clinical Research Associate II in Oncology
This job is no longer accepting applications.
- Develop strong site relationships and ensures 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.Qualifications:
- Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~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
Are you interested?
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.
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