As a Site Investigational Product Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
The Site Investigational Product Specialist will serve as a key contact point between the sponsor and the investigational site for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. This role will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. The Site Investigational Product Specialist will be the key internal and external interface to ensure overall IPPI adherence . He/she will contribute to continuous process improvement, training and mentoring for IPPI.
The tasks undertaken are varied and can include:
- Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials.
- Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable.
- Process risk assessment review where applicable.
- Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team.
- Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment.
- Close collaboration with (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics.
- Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site.
- Review of site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes.
- Collaboration on Investigational Product training material development with key stakeholders.
- Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements.
- Point of contact for the internal study team in the country for questions related to the IP administration.
- Review any modification of IPPI, SIPPM manual, specific forms related to IP administration and dosing during the applicable phases of the trial.
- Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. nurses, investigators,…).
You are:
- A degree in general nursing is required.
- 3- 4 years of recent clinical/hospital experience is required;
- 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.
- Minimum of 5+ 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.
- Minimum of 5+ years’ experience with various IP administration routes (IV, SC, IM, intravesical, intraperitoneal, blood- and cell products) and priming and flushing procedures required.
- Extensive knowledge on Administration related requirements (background of anatomy and physiology, metabolism of drugs and IP, hygienic requirements, how to handle hazardous drugs)
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.
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