Research Nurse Practitioner / Physician Assistant

ProSciento, Inc•Chula Vista, CA

21d•$60 - $75

About The Position

With physician supervision, provides medical oversight and management of human clinical trials while ensuring the integrity of the studies and the safety and well-being of human subjects. Performs duties in accordance with company’s values, policies, and procedures. This role will be assigned to weekend and holiday shifts. Full-time staff will be required to participate in the on-call rotation.

Requirements

Graduation from nurse practitioner program accredited by ANCC (American Nurses Credentialing Center) or AACN (American Association of Critical Care Nurses) in conjunction with passing the American Academy of Nurse Practitioners National Certification Board and two years of clinical experience in adult medicine and/or equivalent combination of education and experience.
Knowledge of current principles, methods, and procedures for the delivery of medical evaluation, diagnosis, and treatment.
State of California Certified Nurse Practitioner or Physician Assistant.
Current ACLS certification or ability to be certified within one month of employment required.
Columbia-Suicide Severity Rating Scale (C-SSRS) training is required and will be provided by the company.
GCP training is required and will be provided by the company.
Highly developed verbal and written communication skills.
Ability to read and interpret documents such as safety rules, Work Instructions (WIs), Standard Operating Procedures (SOPs), medical terminology and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of the organization.
Ability to calculate formulas.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several concrete variables in standardized situations.
Knowledge of the current MS Office Word and Excel.

Responsibilities

Reviews study protocols and serves as Sub-Investigator on all studies.
Provides medical expertise and judgment in support of all study processes.
Performs screening and medical assessment of subjects, including assessment of medical histories and physical examinations, review of I/E criteria, and determination of suitability of study volunteers for enrolment under the supervision of the research physicians.
Interprets screening and diagnostic procedures and tests as well as performs follow-up actions as indicated within the scope of clinical trials.
Supervises clinical procedures for all ongoing clinical studies at ProSciento.
Maintains detailed, legible, and confidential study records in accordance with study protocols.
Trains other clinical staff on studies, as needed.
Ensures safety and well-being of all study volunteers/participants.
Reviews, assesses, and performs appropriate follow-up of laboratory, ECG, telemetry, and other data collected on study volunteers/participants on a continuous basis.
Assesses and manages adverse events.
Assesses and manages any medical emergencies.
Participates in safety assessments as appropriate.
Ensures that all studies are conducted in compliance with their respective protocols, Good Clinical Practices (GCP), and applicable regulations.
Completes and reviews source documents and case report forms, as appropriate.
Contributes and participates actively in continuous quality improvement.
Supports scientific publications.
Provides medical supervision for nursing and clinical operations staff.
Acquires information on the most current developments and trends in the field, through educational programs, in-services, professional associations, and literature.
May be required to lead or participate in inter-departmental trainings.