Nurse Practitioner

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.

Schedule

• Assigned to weekend and holiday shifts.
• Generally scheduled for 4-hour shifts on weekends.
• Holiday shifts can be 4–8 hours in duration.
• Onboarding requires a minimum of 1 day per week for onsite training (up to 8 weeks/64 hours).
• Full-time staff will participate in the on-call rotation.

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 inclusion/exclusion criteria, and determination of suitability of study volunteers for enrollment under the supervision of 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.
• 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 and 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 current developments and trends in the field through educational programs, in-services, professional associations, and literature.
• May lead or participate in inter-departmental trainings.

Competencies

• Timely Decision Making: Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to perform the job at a high level of accomplishment.
• Informing: Provides the information people need to do their jobs and feel valued; ensures timely information for accurate decision-making.
• Priority Setting: Focuses on what’s important; eliminates distractions and roadblocks to achieve goals.
• Time Management: Uses time effectively and efficiently; values time and broadens the scope of activities.

Requirements

• Graduation from a nurse practitioner program accredited by ANCC (American Nurses Credentialing Center) or AACN (American Association of Critical Care Nurses).
• Passing the American Academy of Nurse Practitioners National Certification Board exam.
• Two years of clinical experience in adult medicine or equivalent combination of education and experience.
• Knowledge of current principles, methods, and procedures for medical evaluation, diagnosis, and treatment.
• State of California Certified Nurse Practitioner or Physician Assistant license.
• Current ACLS certification or ability to obtain within one month of employment.
• Columbia-Suicide Severity Rating Scale (C-SSRS) training (provided by the company).
• GCP training (provided by the company).

Skills

• Language Ability: Highly developed verbal and written communication skills. Ability to read, interpret, and write documents such as safety rules, work instructions, SOPs, medical terminology, and procedure manuals. Ability to speak effectively before groups.
• Math Ability: Ability to calculate formulas.
• Reasoning Ability: Ability to apply common sense to carry out instructions and deal with problems involving concrete variables.
• Computer Skills: Proficiency in Microsoft Office Word and Excel.