Position Summary
Under the direct supervision of the Site Manager, the Adult/Family Nurse Practitioner will screen prospective participants for study eligibility and obtain informed consent; obtain medical histories and conduct physical examinations of all screened and enrolled study participants; prescribe study medications; administer infusion therapy; assess symptoms and medication side-effects; review laboratory results and assess reported adverse events related to study participation in HIV prevention clinical trial, addiction trials and COVID-19 prevention trials. The Adult/Family Nurse Practitioner will be responsible for the collection, documentation and completion of case report forms as per study protocols and study-specific procedures.
Responsibilities
• Obtain medical histories, conduct physical examinations and assess symptoms of all screened and enrolled study participants in accordance with protocol requirements. (15%)
• Administer study product and perform other protocol-defined procedures including but not limited to intravenous infusions, injections, vital signs, rapid HIV testing and phlebotomy. (10%)
• Complete study-related case report forms and source documentation per protocol, review all screening laboratory results to determine participant study eligibility and assess and manage reported symptoms and other adverse events. (15%)
• Perform the consent process and obtain signed informed consent prior to initiating any protocol-defined procedures. (5%)
• Write and sign study specific prescription and corresponding New York State prescription for study drugs. (15%)
• Conduct study visits in the field and the mobile van unit. (10%)
• Participate in quality assurance activities in collaboration with the site’s Data Manager and the network’s Statistical and Data Management Center and maintain accurate, comprehensive study records and source documentation. (5%)
• Manage and oversee study staff on day-to-day activities of study implementation and administration. This includes clinical procedures per protocol and quality control and continuous quality improvement, ensuring site compliance with study protocols, all relevant procedures, policies and regulations. Understand and adhere to study protocols, and other appropriate regulations, procedures and policies. (15%)
• Maintain confidentiality of study participants and adhere to principles of Human Subjects Protection (HSP) and Good Clinical Laboratory Practice (GCLP). (5%)
• Perform other related duties as assigned. (5%)
Minimum Qualifications
• Bachelor’s degree in Nursing and graduation from an accredited Nurse Practitioner program and four years of related experience
• Current New York State NP and RN license• At least two years of experience as either an Adult or Family Nurse Practitioner • Current BLS or ACLS (or both) certification • At least two years of research experience […]
