Nurse Practitioner or Physician Assistant (Full time)

Key Responsibilities Department: Operations Location: Boston Clinical Trials | Roslindale, MA Alcanza is a growing multi‑site, multi‑phase clinical research company with a network of locations across 20+ states and Puerto Rico. We have an established presence across Phase I‑IV studies in vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Nurse Practitioner or Physician Assistant will be assigned as a Sub‑Investigator in research studies. As delegated by the Principal Investigator (PI), the NP or PA will perform physical and medical history assessments and assist the PI with medical management of subjects on a trial. The Sub‑Investigator may also function as a Clinical Research Coordinator and coordinate daily clinical research activities according to the organization’s SOPs, GCP, and FDA/ICH guidelines. Essential Job Duties Under the direction of the Principal Investigator, perform the functions of Sub‑Investigator on research studies. Ensure IRB‑approved protocols are implemented and followed. Execute the informed consent process and monitor patient status and safety; collect and organize research data; schedule and conduct study‑specific training and site in‑services to study‑related staff on new or amended protocols; educate patients and their families about treatments and possible side effects. Protect patients’ welfare and rights as a research subject. Perform research protocol procedures including, but not limited to physical exams, injections, IVs, medical history review, vital signs, laboratory results, and adverse event assessment. Mix and/or dispense investigational product and instruct subjects on usage and potential drug interactions. Participate in 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 in 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. Work with the Principal Investigator to maintain high quality and patient safety. Establish rapport with sponsor representatives and maintain frequent contact with patients, relatives, doctors, sponsors, and all levels of the company. May perform the role of Clinical Research Coordinator 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. Demonstrate practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, etc. Maintain accountability of own professional growth and development. Perform all other duties as requested or assigned. Skills, Knowledge, and Expertise Minimum Qualifications A Bachelor’s degree and a minimum of 2 years of clinical experience. A current, active license in good standing to practice as an advanced practice professional in the state of practice is required. Research experience is a plus. Bilingual (English/Spanish) proficiency is a plus. Required Skills Proficiency with computer applications such as Microsoft Office, email, electronic health records, and web applications. Typing proficiency (40+ words per minute). Perform basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, reconstitution of investigational product, injections, and IVs. Strong organizational skills and attention to detail. Well‑developed written and verbal communication skills. Well‑developed interpersonal and listening skills and ability to work independently as well as with co‑workers, subjects, managers, and external customers. Ability to handle multiple tasks and adapt to changing workloads and priorities. Professionalism, respect for others, self‑motivation, and a strong work ethic. High degree of integrity and dependability. Ability to work under minimal supervision, identify problems, and implement solutions. Ability to handle highly sensitive information confidentially and in compliance with HIPAA guidelines. Benefits Full‑time employees working at least 30 hours per week are eligible for benefits, with coverage beginning on the first day of the month following hire date. Medical, dental, vision, life insurance; short and long‑term disability; health‑savings accounts; supplemental insurances; and a 401(k) plan with a safe‑harbor match are offered. #J-18808-Ljbffr Alcanza Clinical Research