Provides ethical, safe, and holistic nursing care of clinical research participants.
Focuses on the clinical nursing requirements of PCRU-NH study protocols that yield reliable, high quality research outcomes, and valid scientific data and findings.
Performs the hands-on collection, measurement and recording of data pertaining to clinical research studies at Pfizer New Haven Clinical Research Unit (PCRU-NH).
Works individually and as part of a multi-disciplinary team to effectively and accurately execute protocol driven clinical research studies maintaining subject safety and data integrity.
Provides direct, face-to-face instruction and support to the volunteers of clinical research studies, with an emphasis on volunteer safety and comfort including basic first aid and supportive nursing care as needed.
Provides holistic nursing and medical care including basic first aid within the scope of professional licensure.
Executes clinical research studies in accordance with protocol requirements and internal SOPs, guidelines, work instructions, and process maps.
Administers investigational product in accordance with protocol specified instructions and local SOPs.
Administers concomitant drug and non-drug treatments based on subject presentation and medical provider recommendation.
Maintains proficiency in multiple methods and forms of data collection (i.e., ECGs, V/S, venipuncture, telemetry, etc.).
Assists in human biological sample management including generation of identifying labels, collection and associated source document completion as needed.
Participates in all required clinical training. Maintains up-to-date records and transcripts at all times.
Records adverse events with referral to medical providers for evaluation & treatment.
Performs electronic and diagnostic measurements including audiograms, electrocardiograms, visual exams, and other novel devices.
Performs and records physical measurements including vital signs and body measurements.
Utilizes EHR systems to generate day-to-day study needs such as volunteer badges and study rosters.
Provides instructions and assistance to clinical research volunteers.
Monitors daily usage and maintains adequate levels of clinical supplies.
Maintains equipment log & calibration records.
Reviews data output on a daily basis to ensure the highest level of quality and accuracy.
Assists in the delivery of improved training program in the clinical preceptor role.
Co-leads progression of training on specific study procedures in the subject matter expert (SME) role.
Required to attend and participate in training for collection of additional data types identified by protocol.
Supports other additional clinical functions as delegated by Clinical Services Manager and/or Director of Clinical Services.
Participates in other extraneous and innovative projects within the Unit as delegated by Clinical Services Manager and/or Director of Clinical Services.
Minimum of an Associate in Science in Nursing degree.Bachelor of Science in Nursing strongly preferred.
qualifications include minimum of 1-2 years of work experience in clinical research trials as data collector, research nurse, or clinical coordinator.
State of Connecticut licensure as a Registered Nurse (RN).
Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.
Understanding and comprehension of scientific writing.
Excellent verbal and written communication skills.
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.
Current certification in Basic Life Support (BLS) required.
Current certification in Advanced Cardiac Life Support (ACLS) required.
Required availability to work beyond normal work hours as needed (i.e. evenings, nights, and weekends)
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N (Other) (United States of America) Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.