ICON Clinical Research Set Up Specialist in Farmingdale, New York
Job Title: Set Up Specialist
Location: Farmingdale NY- open for remote work
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.
Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.
Serve as the primary liaison with the sponsor during the setup phase of the study
Own the Client Laboratory Worksheet (CLW) completion process. Ensure all information and specifications are captured in the Client Laboratory Worksheet (CLW) and are accurate by taking into account the study protocol, sponsor requests, ICON Laboratory standards, and requests/recommendations from internal operational groups.
Working independently, coordinate and manage the completion of the Client Laboratory Worksheet (CLW) and communication of information as required to the other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).
Serve as the subject matter expert for the Sponsor in guiding them through a successful setup process by drawing on past experiences and standards. Highlight any risks associated with the study to the sponsor and internal parties including participating in internal risk assessment and other operational meetings as necessary.
Communicate major decisions or timeline changes during setup with the Laboratory Project Manager and other laboratory staff as necessary (and ICON Clinical CRO if appropriate). Independently manage the laboratory setup timeline.
Must have an in-depth knowledge of Laboratory database and how amendments to the database will affect different operational areas of laboratory and be able to efficiently anticipate and communicate these changes to all internal and external parties including sponsor clinical and data management teams.
Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.
Lead projects in respect to setup process improvement and serve as a member for other projects utilizing subject matter expertise.
Contribute toward the maintenance of setup related documents such as the CLW template, Laboratory Manual template, Requisition template, and other items as necessary.
Serve as a resource in respect to the overall laboratory setup process for internal parties such as Project Management and the Laboratory.
What you will need:
3-5 years relevant experience in a similar position
Bachelors degree or local equivalent, preferably Science related
Prior relevant experience working in a clinical laboratory, clinical trials, project management or customer management/account management role in a life sciences related organization
Working familiarity with MS Word and Excel
Excellent oral and written communication skills
Ability to multitask and perform effectively in spite of shifting priorities and workload
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.