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Nurse Practitioner or Physician Assistant
2 months ago
The Nurse Practitioner or Physician Assistant will be assigned as Sub-Investigator in research studies. As delegated by the Principal Investigator (PI), will perform physical and medical history assessments, and assist the PI with the medical management of subjects on a trial. The Sub Investigator may also function in a Clinical Research Coordinator role and coordinate daily clinical research activities according to the organization’s SOPs, GCP, and FDA/ICH guidelines.
Key ResponsibilitiesEssential Job Duties:
- 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; educates 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. May 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;
- Assist site management with support in change management and process improvement;
- Assist and participate with new staff training and mentoring;
- Assist 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 adheres 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.
Minimum Qualifications: A Bachelor’s degree and a minimum of 2 years of clinical experience, or an equivalent combination of education and experience is required. Active license (in good standing) to practice as an advanced practice professional in the state of practice is required. 1+ years research experience is highly preferred. BLS/ACLS certified required. Bi-lingual (English / Spanish) proficiency is a plus.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications
- Ability to type proficiently (40+ wpm);
- Performing 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.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- 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.
Benefits
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
