Sub-Investigator; Nurse Practitioner

Overview

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career!

As an Sub-Investigator (Nurse Practitioner), you will deliver high quality, patient-centered care through mobile health clinics at our permanent community Mobile Research Unit or occasionally through home health visits. The Sub-Investigator (Nurse Practitioner) is responsible for ensuring participant safety, data integrity, data quality, and maintenance of protocol standards in various therapeutic areas. As an Advanced Practitioner, you will assist various virtual Principal Investigators (vPIs), through delegated authority, with conducting clinical trials per federal, state, and institutional guidelines, while learning the responsibilities during all phases of trials from pre-study implementation through study closure.

In addition to study processes and procedures, the Sub-Investigator (Nurse Practitioner) will support our fleet team with daily unit maintenance, temperature monitoring, and inventory management. This role is all encompassing to ensure efficient study conduct and site procedures.

Qualifications

• Education:
  
  Advanced practice degree NP
• Experience:
  
  Two (2) year of experience as an Advanced Practitioner, two (2) year of experience starting and performing phlebotomy, IVs, subcutaneous injections, collecting vital signs, ECG, and urine collection. One (1) year of recent clinical research experience preferred.
• Computer
  
  Skills:
  
  Excellent computer Skills, including Microsoft Outlook, Word, Excel, and PowerPoint.
• Certificates & Licenses: current unrestricted licensure to practice as an Advanced Practitioner (NP or PA) in the state to which the candidate is assigned. Current BLS certification required. CITI, GCP, and IATA preferred.

• Other Knowledge, Skills, And Abilities

• Excellent verbal and written communication.
• Experience collecting, processing, and shipping lab specimen(s).
• Use of considerable judgment/critical thinking in application of procedures, nursing assessment techniques, practices, and policies to work problems, organization, and administration of research or outpatient clinic.
• Working knowledge of federal, state, and local laws and regulations governing research.
• Ability to provide patient-centric focus.
• Adaptability/flexibility to react positively to changes in work environment. Initiative to improve productivity and quality of work.
• Ability to plan and organize work in logical and efficient manner.
• Ability to manage time delicate projects to meet deadlines.
• Strong attention to detail.
• Excellent ability to establish and maintain effective working relationships.
• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged periods of standing, bending, and reaching.
• Must be able to lift up to 50 pounds at times.
• Have the ability to travel, a valid state driver license and able to drive a car, proof of adequate automobile insurance coverage for the state of residence.
• Ability to travel regionally by car or nationally by plane.
• Possess cellular phone, reliable transportation, and access to the internet.

Essential Functions/Areas Of Accountability

• Serves as a leader to the study team to execute clinical trials by mentoring and training staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.
• Screens and confirm subject eligibility in assigned clinical trials in accordance with the Health Insurance Portability and Accountability Act (HIPAA) standards.
• Performs pediatric, adult, and geriatric participant visits, including but not limited to medical history collection, medication reconciliation, physical exam, and health education.
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs.
• Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• As delegated, administers medications, investigational products, and vaccinations.
• As delegated, assess serious and adverse events as related to investigational product.
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Perform clinical duties (e.g., Drug preparation and administration, phlebotomy, ECG, lab processing) within scope.
• Assists in coordinating research subject's consent and entry into appropriate research studies ensuring that all…