Clinical Research Associate (I,II and Senior)

				Overview:

As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities:

* 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 eTMF accurate and current.
* Support inspections and audits-and even lead them when needed.
* Mentor and co-monitor with peers to share best practices.

Qualifications:

* 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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