Clinical Study Coordinator

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.

Overview of the role: Title: Clinical Study Coordinator

Location: On-Site Salt Lake City UT USA

Summary: The Clinical Study Coordinator will provide administrative support for clinical trial management by organizing and coordinating clinical studies and local teams for clinical research trials. Additionally, they will monitor study timelines, and manages clinic floor regarding equipment set up and scheduling meetings.

Primary Responsibilities:

• Participates in the assessment, preparation and implementation of studies for the clinic to ensure timely and high-quality study output.

• Provides support in reviewing and assessing protocol, clinic budget, case report forms, informed consent forms and volunteer information.

• Coordinates availability of study materials and equipment, creation of corresponding instructions, validation and verification of testing new equipment and approval of invoices.

• Communicates any changes in scope or cost to management and escalates issues and/or major deviations as needed.

• Prepares and maintains clinical documents. Monitors submission of documents to the Institutional Review Board (IRB).

• Supports the organization and preparation of clinic specific meetings, site invitation visits and monitoring visits in cooperation with the data entry staff.

• Assists in the closing of the clinical conduct of the study by coordinating restitution and/or storage of study materials, equipment and documents and study evaluation.

• Assists with managing the clinic floor by answering questions, helping with setup, modifying schedules, etc.

• Assists with the planning and coordinating of outpatient visits.

• Tracks study specific training.

To be successful in the role, you will have:

• Associates Degree

• 2 years of relevant experience

• Good knowledge of ICH/GCP guidelines

• Good knowledge of internal and external regulations, standard operating procedures and work instructions

• Good knowledge of pharmacokinetics and pharmacodynamics

• Good written and oral communication skills

• Good ability to conduct authorized medical procedures and measurements such as sampling, CPR, Immediate Life Support, etc.

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.