JOB 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.

JOB 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.

QUALIFICATIONS

Must have

“Life Science/Biomedical” or “Health Care” related education or experience.

Current BLS/ILS/ACLS certification and 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

Experience in pharmaceutical or medical research position is an asset

Nice To Have

Bachelor’s degree in nursing

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:

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

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

Schedule

Rotational (evenings, nights and weekends)

Other Job Details

Work Location Assignment: On Premise

The salary for this position ranges from $31.82 to $53.04 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Connecticut - New Haven location.

Relocation assistance may be available based on business needs and/or eligibility.

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 provider’s 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.  This position requires permanent work authorization in the United States.

Medical