ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center 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:Title: Clinical Data Quality AssociateLocation: On-Site San Antonio TX - 100% on siteJob Type: Full-Time, PermanentDuties:
Reviews and verifies clinical trial data for alignment with industry standards, regulations, protocol, and internal processes.
Identifies and develops new methods for QC of study documentation.
Gathering study specific binders for data entry and QC review.
Coordinating with study management teams for query resolution.
Reviewing study protocols against eCRFs, Completion Guidelines, and study source documents.
Maintaining study timelines for data entry and query resolution.
Archiving study documents.
Collaborates with internal and external reviewers on resolution of data quality inquiries.
Good knowledge of Medical Terminology.
Good knowledge of the International Conference of Harmonization (ICH) document, Good Clinical Practice (GCP), and good documentation practices in clinical research.
Solid attention to detail and prioritization skills.
Reviews and verifies clinical trial data for alignment with industry standards, regulations, protocol, and internal processes.
Identifies and develops new methods for QC of study documentation.
Gathering study specific binders for data entry and QC review.
Coordinating with study management teams for query resolution.
Reviewing study protocols against eCRFs, Completion Guidelines, and study source documents.
Maintaining study timelines for data entry and query resolution.
Archiving study documents.
Collaborates with internal and external reviewers on resolution of data quality inquiries.
Good knowledge of Medical Terminology.
Good knowledge of the International Conference of Harmonization (ICH) document, Good Clinical Practice (GCP), and good documentation practices in clinical research.
Solid attention to detail and prioritization skills.
To be successful in the role, you will have:
Read, write, and speak fluent English; fluent in host country language required
High School Diploma, G.E.D., or secondary vocational education required
1+ years of clinical research experience
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.
