CRA I

 

$ads={1}

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 Site Investigational Product Specialist (SIPS) will serve as a subject matter expert for nursing
administration as it relates to the process and procedure of the IPPI (Investigational Product Preparation and
Administration Instructions), specific to drug administration in the area of clinical research. The SIPS will play
a lead role in the development of safe, efficient, and effective IP administration in clinical trials. The SIPS will
be the key internal and external interface to ensure overall IPPI administration adherence. The SIPS will be
co-author of the IPPI, and will be responsible for training slide development, training level assessment
evaluation, and internal staff training. The SIPS will give input in ancillary supply selection and ancillary supply
related questions, study feasibility, site assessment and mentoring for IPPI. He/she will contribute to
continuous IPPI process improvement.

LEVEL 1 (BASE)

• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory

requirements, etc.

• Co-author of the IPPI and review/provide input on all specific forms related to IP administration and

dosing for all types of trials with an IPPI such as:
o Administration routes (IV/SC/IM/intravesical/intraperitoneal/blood- and cell products, etc.)
o IV access devices (central vs peripheral, Hickman, PICC, Port, PIV, midline, etc.)
o Priming and flushing procedures
o Filters
o Hygienic standards
o Medical devices (IV pumps, syringe pumps, plasma therm, etc.)

• Support IPPI related initiatives and working groups. Actively participate in IPPI and all other nursing

practice and scientific discussions. Track and integrate evolving trends in nursing practice into current
and future IPPIs.

• Provide input in ancillary supply selection, Ancillary Supply Questionnaire and coordinate ancillary

supply related questions in close collaboration with the Ancillary Support Associate (ASA)/ Site
Manager (SM).

• Develop IP administration training materials.
• Set up and attend mock runs on IPPI administration before first formal IP administration at the

investigational site if deemed necessary.

• Support SM/IDM with resolving site IPPI related issues and site training (if applicable) according to

local guidelines and blinding requirements.

• Assist in site assessments/pre-trial assessment activities and study feasibility, providing

recommendation from local area about site/investigator selection in collaboration with the trial team
and develop IP related questions for site feasibility questionnaire.

• Attend site initiation visit to support SM if deemed necessary.

A degree in general nursing is required.
3- 4 years of recent clinical/hospital experience is required; however, other relevant experience
may be considered by the hiring manager when considering the candidate’s eligibility.
Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology
Therapeutic Area)
Min. 3 years’ experience with various IP administration routes (IV, SC, IM)
Clinical trial research experience.

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

$ads={2}

 

.