Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish) - Nurse Practitioner at Alcanza Clinical Research Sugar Land, TX

Benefits

Qualifications

• •Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish)
• •Nurse Practitioner or Physician Assistant - Sub-Investigator (Must be Bi-lingual - English/Spanish)
• •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
• •BLS/ACLS certified required
• •Bi-lingual (English / Spanish) proficiency is required
• •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
• •14 more items(s)

Responsibilities

• •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
• •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
• •20 more items(s)