In-House CRA - Southampton or Marlow
About the role
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In-House CRA - Southampton or Marlow
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.
The Role
Become familiar with ICON's SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
Serve as the primary in-house contact for sites and investigators participating in studies
Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
Take responsibility for project tasks and sees these tasks through to successful completion, with support.
Maintain a professional interpersonal relationship with study team, sites, and Sponsors
Participate in QA Audits as needed.
Regularly attend and gives to project specific and departmental meetings
Ability and willingness to travel as needed (drive and fly)
Maintain Sponsor and patient confidentiality
Other duties as assigned
To be successful in the role you'll need:
Minimum Bachelor's degree in a life science
At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
Understanding of ICH GCP Compliance
Excellent communication and organizational skills
To be a phenomenal teammate
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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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