Clinical Study Coordinator

The Clinical Study Coordinator provides administrative support for clinical trial management by organizing and coordinating clinical studies and local teams for clinical research trials, monitors study timelines, and manages clinic floor regarding equipment set up and scheduling meetings.

Location: On-Site in our Lenexa, KS lab.

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 this role, you will have:

• Understanding of ICH/GCP guidelines
• Knowledge of internal and external regulations, standard operating procedures and work instructions
• Knowledge of pharmacokinetics and pharmacodynamics
• Excellent written and oral communication skills
• Ability to conduct authorized medical procedures and measurements such as sampling, CPR, Immediate Life Support, etc.
• Associate's degree or international equivalent

Physical Requirements

Workistypicallyperformed inanclinicenvironment,usingsimple, easymuscularmovements,involvingonlythehandlingof light materials,tools, orequipmentandmayrequirelongperiodsof standingandwalking.

Benefits of Working in ICONOur 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.