Senior Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**[Senior Clinical Research Associate]**

**[Thailand]**
- Performing monitoring visits according to plan, document actions and follow up on action plans Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators
- and accountability for patient recruitment strategies
- Train and guide site staff in the protocol and trial procedures to minimize protocol deviations(PDs)
- Train site staff in safety information handling and systems
- Know and meet all local and company requirements with respect to safety reporting
- Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
- Identify potential risks and proactively take action to prevent or mitigate
- Collaborate with Data Management/logistics in resolving queries
- Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
- Manage trial product requirements, incl. temperature deviations and training of site staff
- Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
- Ensure collaboration with and deliverables from vendors locally, if applicable
- Collection and management of essential documents
- Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
- Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
- Minimum of 5+ years on site CRA experience to include different visit types, SEV, SIV, MV, COV.
- Willing to mentor and train junior colleagues on monitoring principles and activities
- Ability to interpret data and review for reporting trends: Eg: SAEs, IPDs and Drug Dosing Deviations etc.
- Demonstrate good knowledge and appropriate understanding of inspection readiness
- Ability to identify root cause of issues clearly
- Ability to identify corrective and preventative actions to issues or findings
- Understand and explain trial endpoints
- Ability to support CTM with vendor related issues
- Sc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region
- Ideally experience from a similar position in the pharmaceutical industry or Clinical Research
- Organization (CRO). Other experience may also be relevant, e.g. as study staff at a clinical research site.
- Ability to build and maintain relationships with sites

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.