Overview:

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 ad ministration 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. The SIPS will mainly focus on SIPS tasks for trials with an IPPI.

Deliverables:

• 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:

  • Administration routes (IV/SC/IM/intravesical/intraperitoneal/blood and cell products, etc.)

  • IV access devices (central vs peripheral, Hickman, PICC, Port, PIV, midline, etc.)

  • Priming and flushing procedures

  • Filters

  • Hygienic standards

  • 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.

• Responsible for internal team training of administration process for all versions of the IPPI according to internal Standard Operating Procedures (SOPs)/Work Instructions (Wls)/Instructions for Use (IFUs) and policies for internal staff.

• Point of contact for the internal study team (LTM/SM/IDM) for questions and issue resolution related to the IP administration.

• Conduct ongoing dialogue with customers to understand site perspectives and enhance educational efforts as it relates to study drug administration.

• Present data and information in a manner appropriate to the audience, identifying groups that would benefit from presentations and information.

• Perform all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities, vTMF filing, CTMS).

Metrics/KPIs:

• Metrics/KPIs governing these services are outlined in the QOP document.

Interfaces - Primary/Other:

• Primary interfaces: Provider Functional Manager, Global Trial Leader, Country Trial Manager, Local Trial Manager, Site Manager, Pharmacy Investigational Product Specialist, Site Investigational Product Specialist, Ancillary Support Associate, Independent Drug Monitor Manager, Independ ent Drug Monitor, DPDS-team, Clinical Supply Integrator, CMC Leader, Study Responsible Physician, Study Responsible Scientist, Global Clinical Research Associate, CTL&D Specialist

• Other Interfaces: Quality and Compliance Manager/Specialist, R&D/Local Operating Company staff (including Medical Affairs), Bioresearch Quality and Compliance (BRQC), Investigators and their delegates at site (trial site personnel).

Education and Experience Requirements:

• 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

• Clinical trial research experience.

• Knowledge of the drug development process and on International Council on Harmonization (ICH)/Good Clinical Practices (GCP) is an asset.

• Strong leadership, process initiative, influencing and mentoring skills.

• Experience working with virtual meeting software, Microsoft suite, including word, power point and excel and clinical systems.

• Innovative and creative mindset with strong attention to details.

• Strong written, oral, and interpersonal communication skills.

• The ability to multi-task, work on multiple trials in parallel in different disease areas.

• The ability to collaborate with all levels of management across a matrix organization.

• Problem solving skills with ability to make decisions. to manage difficult clinical scenarios

• Must be proficient in speaking and writing in the country language and English.