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.
QUALIFICATIONS / SKILLS
- 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
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.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 assetPREFERRED QUALIFICATIONS
- Nursing and emergency interventions are appropriate, immediate, and demonstrate excellent assessment skills and standard of care
- 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.
- Good written and verbal skills in French and Dutch are essential (Brussels CRU 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)
- Excellent verbal and written communication skills
- Able to work effectively in multifunctional, interdepartmental management teams.
- Change agile: open and receptive, flexible and adaptable Business oriented
- Action-oriented: achieve departmental goals
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
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 interventionNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position is for the 3rd shift (Nights only)
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.