Under Direct Supervision of Clinical Floor Lead; The Clinical Research Nurse;
- 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.
- Required 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.
- Current certification in Basic Life Support (BLS) required.
- Current certification in Advanced Cardiac Life Support (ACLS) required.
- Bachelor of Science in Nursing strongly preferred.
- 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.
- Required availability to work beyond normal work hours as needed (i.e. evenings, nights, and weekends).
- Flexibility for varying shifts, Weekends as needed.
Other Job Details:
- Last Date to Apply for Job: November 23, 2020
- Eligible for Employee Referral Bonus: YES