ROLE SUMMARY

The Clinical Research Nursing Provider is a member of the Pfizer Clinical Research Unit which is a global organization with Clinical Research Units in New Haven, CT and Brussels, Belgium. The Clinical Research Units operate for the purpose of conducting early clinical trials with healthy volunteers. This individual assures and is responsible for data and sample collection and safety of the trial subjects. This individual focuses on the clinical nursing requirements of PCRU study protocols that yield reliable, high quality research outcomes, and valid scientific data and findings. This individual is also responsible for performing self-daily check on all data for accuracy and completeness, as well as maintaining source documentation. They demonstrate ability and flexibility to work alternative or additional hours internally and externally (weekends/evenings/nights) to provide study activity coverage. They provide direct, face-to-face instruction and support to the trial subjects with an emphasis on participants safety and comfort including basic first aid and supportive nursing care as needed.

ROLE RESPONSIBILITIES

• Executes clinical research studies in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines, and Pfizer SOPs
• Executes and is responsible for protocol required  data and sample collection in accordance with ALCOA standards from screening until last final visit.
• Responsible for volunteer/patient safety including code carts and clinical supplies maintenance and readiness
• Observes and communicates to the medical provider, records, and updates any adverse event. Provides patient care within scope of licensure as needed under the supervision of medical provider.
• Responsible for  self-daily check on data collected during study activities
• Executes and is responsible for multiple study activities including nursing assessment of physiologic response to drug administration, administration of study medications in accordance with protocol specified instructions and local SOPs, administration of  concomitant drug and non-drug treatments based on subject presentation and medical provider recommendation, cardiac monitoring, basic nursing care and emergency interventions
• Maintains proficiency in multiple methods and forms of data collection (i.e., ECGs, V/S, venipuncture, telemetry, etc.). 
• Provides instructions and assistance to clinical research participants.
• Assists in human biological sample management including generation of identifying labels, collection and associated source document completion as needed
• Maintains equipment log & calibration records as needed
• Maintains adequate levels of clinical supplies for data collection, clinical care and emergency readiness.
• At discretion of Clinical Services Manager, functions as an asset owner to keep equipment in functioning order through preventative maintenance and calibration
• Reports and documents any issue/incident/discrepancies in the conduct of a study
• Answers and resolves any query sent by project manager or clinical coordinator

BASIC QUALIFICATIONS

Minimum of a bachelor’s degree in Nursing or equivalent “Life Science/Biomedical” or “Health Care” related education or experience.

Current BLS/ILS/ACLS certification

Current Healthcare licensure as applicable per state/country statute.

Minimum of 2 years of relevant work experience in a health-related discipline including competency in phlebotomy/venipuncture techniques, and performing electrocardiograms is highly preferred.

Experience in pharmaceutical or medical research position is an asset

PREFERRED QUALIFICATIONS

Technical skills:

• Nursing and emergency interventions are appropriate, immediate, and demonstrate excellent assessment skills and standard of care

Computer skills:

• Working knowledge of computers (e-HR) and laboratory data handling acquisition systems and associated issues/risks.
• Experience and understanding of effective electronic and distance communication methods (i.e. Email, Video Conferencing, IM)
• Proficiency in Microsoft (MS) Office and the ability to learn different software programs.

• Scientific/ Clinical/ Research Knowledge:

• Excellent knowledge of medical conditions, medical terminology, nursing and research techniques, and application of clinical research;
• Understanding and comprehension of scientific writing
• Ability to review and understand emerging safety data of a drug candidate and recognize potential serious adverse effects.

• Language skills:

• Good written and verbal skills in French and Dutch are essential (BrusselsCRU only)
• Good written and verbal skills in English are essential (Brussels CRU only)
• Bilingual ability to speak, read, and write Spanish is highly desirable. (New Haven CRU only)

• Communication:

• Excellent verbal and written communication skills

• Other:

• Able to work effectively in multifunctional, interdepartmental management teams.
• Change agile: open and receptive, flexible and adaptable Business oriented
• Action-oriented: achieve departmental  goals

• Customer focus:

PHYSICAL/MENTAL REQUIREMENTS

Manual skills: significant portions of daily assignments involve application of manual skills requiring motor coordination with finger dexterity

Physical effort: duties involve light effort.  Work involves up to 5 pounds/2,5kg of force to lift, carry, push, pull or move objects.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Required to work on shift (week-end/legal holidays/evening/night)

Might be required to work on unsocial hours or overtime to guarantee study execution business continuity.

Might be required to do some intercontinental travels between PCRU and research sites.

Reports to Clinical Services Manager

Functional working relationship with Project Managers, Technical Training Manager, Clinical Coordinators, Systems Administrator, Quality & Compliance Managers and Laboratory Staff. 

Functional working relationship with PCRU Medical Provider staff in areas of medical oversight and intervention