Clinical Research Associate
2 weeks ago
Be the go-to expert and main contact for clinical trial sites from start to finish.
Build strong, lasting relationships with site staff to ensure smooth trial execution.
Monitor clinical sites to ensure data quality and patient safety in line with GCP and study protocols.
Master the study protocol and procedures to support site success.
Drive site readiness by collaborating with cross-functional teams.
Help identify and validate new study sites.
Ensure all regulatory and trial documentation is up-to-date and accurate.
Lead and document site visits (initiation, monitoring, close-out, etc.) with clarity and precision.
Communicate proactively with investigators about protocol, recruitment, compliance, and performance.
Coordinate with internal teams and external partners (vendors, IRBs, regulators) to support study milestones.
Keep systems like CTMS and e TMF accurate and current.
Support inspections and audits—and even lead them when needed.
Mentor and co-monitor with peers to share best practices.
B.
A./B.
S.
preferred with strong emphasis in science and/or biology Min.
1 year of direct monitoring experience Previous experience in oncology trials or ready to monitor oncology trials will be an asset Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively 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 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 Ability to understand and analyze data/metrics and act appropriately Experience with conducting site motivational visit designed to boost site enrollment Capable of managing complex issues, working solution-oriented Performs root cause analysis and implements preventative and corrective action
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