Nurse Practitioner or Physician Assistant (Full time)

Key Responsibilities

• Under the direction of the Principal Investigator, performs the functions of Sub Investigator on research studies.
• Ensures IRB approved protocols are implemented and followed.
• Executes informed consent process and monitors patient status and safety; collects and organizes research data;
• Schedules and conducts study specific training and site in-services to study related staff on new or amended protocols;
• Edicates patients and their families about treatments and possible side effects.
• Ensure and protect the patient’s welfare and rights as a research subject.
• May perform research protocol procedures which may include, but are not limited to: physical exams, injections, IVs, medical history review and assessment, and assessments of vital signs, laboratory results and adverse events.
• Mix and/or dispense investigational product and instruct subjects on usage and potential drug interactions;
• Participates at pre-study and site initiation visits, investigator meetings, and other customer facing meetings, as needed;
• Aid site management with support in change management and process improvement;
• Aid and participate with new staff training and mentoring;
• Aid and guide employees on study specific tasks;
• Utilize and ensure the appropriate equipment is on-site for Universal Precautions for themselves and others in and around areas that may contain potential biohazards;
• Work with the Principal Investigator to maintain high quality and patient safety.
• Establish rapport with sponsor representatives and maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors and all levels of the company;
• May perform role of Clinical Research Coordinator on studies as needed.
• Maintain strict confidentiality of patients, employees and company information at all times and adhere to HIPAA Guidelines;
• Be thoroughly familiar with the protocol, case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study;
• Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs and maintain ongoing regulatory documents;
• Practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc.
• Maintain accountability of own ongoing professional growth and development;
• Performing all other duties as requested or assigned.

Skills, Knowledge And Expertise

• A Bachelor’s degree and a minimum of 2 years of clinical experience.
• An active license (in good standing) to practice as an advanced practice professional in the state of practice is required.
• Research experience is a plus.
• Bi-lingual (English / Spanish) proficiency is a plus.
• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications.
• Ability to type proficiently (40+ wpm).
• Ability to perform basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, reconstitution of IP, injections, and IV’s.
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.