Nurse Practitioner

Clinical Trial Oversight Role

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. Generally, this role will be scheduled for 4 hour shifts on the weekends. Holiday shifts can be 4 - 8 hours in duration. Onboarding requirements will be at minimum 1 day per week for onsite training (up to 8 weeks/64 hours).

Essential duties and responsibilities include the following. Other duties may be assigned at the company's sole discretion.

• 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.
• Full-time staff will be required to participate in the on-call rotation.

Competencies:

• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Informing: Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.
• Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Nurse Practitioner Education and Experience: 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.

Certificates and Licenses: 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.

Language Ability: 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.

Math Ability: Ability to calculate formulas.

Reasoning Ability: 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.

Computer Skills: To perform this job successfully, an individual should have knowledge of the current MS Office Word and Excel.

*General schedule will be 4 hour shifts on the weekends. Holiday shifts can be 4 - 8 hours in duration.