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.
ROLE RESPONSIBILITIES
* 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.
ROLE REQUIREMENTS
* Minimum of an Associate in Science in Nursing degree.
* Bachelor of Science in Nursing strongly preferred.
* 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).
Other Job Details:
* Last Date to Apply for Job: April 12, 2021
* Eligible for Employee Referral Bonus
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Medical
LI-PFE
New York, New York
Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands. The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names. In addition, it offers products that would lose or have lost marketing patent protection; branded generic products; generic sterile injectable products; biosimilars; and anti-infectives under the Lipitor, Premarin family, Norvasc, Lyrica, Celebrex, Viagra, Inflectra/Remsima, Zyvox, Vfend, Revatio, Inspra, Medrol, Sulperazon, Fragmin, Tygacil, Nivestim, and Retacrit, Ixifi Infliximab BS names.
Further, the company is also involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration and/or co-promotion agreements with Bristol-Myers Squibb Company, Astellas Pharma US, Inc., and Oncolytics Biotech Inc.; licensing agreement with BionTech AG; strategic alliance with Verily Life Sciences LLC; and collaboration agreements with Pfizer, Merck & Co., Inc., and Eli Lilly & Company, as well as with Merck KGaA and Nektar Therapeutics to develop a therapy for treating pancreatic cancer. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.