Clinical Research Nursing Provider

Role Summary

The Clinical Research Nursing Provider is a member of the Pfizer Clinical Research Unit responsible for data and sample collection and safety of trial subjects, focusing on nursing requirements of study protocols to yield high quality research outcomes and valid data. The role includes self-audit of data, maintaining source documentation, and providing direct, face-to-face instruction and support to trial subjects with emphasis on safety and comfort, including basic first aid and supportive nursing care. Flexibility to work weekends/evenings/nights as needed for study coverage.

Responsibilities

• Executes clinical research studies in accordance with scientific, medical, and ethical principles, regulatory requirements/guidelines, and Pfizer SOPs.
• Executes 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 the scope of licensure as needed under the supervision of a medical provider.
• Maintains self-daily check on data collected during study activities.
• Executes multiple study activities including nursing assessment of physiologic response to drug administration, administration of study medications per protocol instructions and SOPs, administration of concomitant treatments, cardiac monitoring, basic nursing care and emergency interventions.
• Maintains proficiency in multiple data collection methods (ECGs, vital signs, venipuncture, telemetry, etc.).
• Provides instructions and assistance to clinical research participants.
• Assists in human biological sample management including labeling, collection, and source document completion as needed.
• Maintains equipment log and calibration records as needed.
• Maintains adequate levels of clinical supplies for data collection, clinical care, and emergency readiness.
• Functions as an asset owner to keep equipment functioning through preventative maintenance and calibration (at the discretion of the Clinical Services Manager).
• Reports and documents any issue/incident/discrepancies in the conduct of a study.
• Answers and resolves queries from the project manager or clinical coordinator.

Qualifications

• Minimum of a bachelor‚Äôs degree in nursing or equivalent Life Science/Biomedical/Health Care 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; competency in phlebotomy/venipuncture and performing electrocardiograms is highly preferred.
• Experience in pharmaceutical or medical research position is an asset.

Skills

• Nursing and emergency interventions with appropriate, immediate response and excellent assessment skills.
• Working knowledge of computers (e-HR) and laboratory data handling systems; familiarity with electronic and distance communication methods (email, video conferencing, instant messaging).
• Proficiency in Microsoft Office and ability to learn new software.
• Knowledge of medical conditions, terminology, nursing and research techniques; ability to review and understand emerging safety data and recognize potential serious adverse effects.
• Strong written and verbal communication in French and Dutch (Brussels CRU) or English (Brussels CRU); Spanish language skills are desirable (New Haven CRU).
• Excellent verbal and written communication skills; ability to work effectively in multifunctional, interdepartmental teams; adaptable and action-oriented.

Education

• Bachelor‚Äôs degree in nursing or equivalent related field; active licensure as applicable.

Additional Requirements

• On-premise work location.
• Note: Travel not specified; roles may require flexibility for extended hours as needed for study coverage.