Nurse Practitioner / Physician Assistant

Alcanza Clinical Research is seeking a Nurse Practitioner or Physician Assistant to serve as a Sub-Investigator at one of our multi-site clinical research locations across the United States and Puerto Rico. In this role, you will support the Principal Investigator in conducting Phase I-IV clinical trials across therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. You will perform medical assessments, manage study protocols, ensure patient safety, and coordinate daily clinical research activities in compliance with GCP, FDA, and ICH guidelines.

Clinical Setting

Alcanza operates a national network of clinical research sites conducting studies across multiple therapeutic areas and phases of development. You will work in a research environment focused on accelerating the development of new therapies while maintaining the highest standards of patient care and regulatory compliance.

Responsibilities

• Perform functions of Sub-Investigator on assigned research studies under the direction of the Principal Investigator
• Ensure IRB-approved protocols are implemented and followed
• Execute informed consent process and monitor patient status and safety
• Collect, organize, and manage research data
• Schedule and conduct study-specific training and site in-services for staff on new or amended protocols
• Educate patients and families about treatments and possible side effects
• Ensure and protect patient welfare and rights as research subjects
• Perform research protocol procedures including physical exams, injections, IVs, medical history review and assessment, vital signs assessment, laboratory result review, and adverse event assessment
• Mix and/or dispense investigational product and instruct subjects on usage and potential drug interactions
• Participate in pre-study visits, site initiation visits, investigator meetings, and customer-facing meetings as needed
• Assist site management with change management and process improvement initiatives
• Participate in new staff training and mentoring
• Guide employees on study-specific tasks
• Utilize appropriate equipment and maintain Universal Precautions for yourself and others in areas that may contain biohazards
• Work with the Principal Investigator to maintain high quality standards and patient safety
• Establish and maintain rapport with sponsor representatives and frequent communication with patients, relatives, physicians, pharmaceutical sponsors, and company personnel
• May perform the role of Clinical Research Coordinator on studies as needed
• Maintain strict confidentiality of patient, employee, and company information in compliance with HIPAA guidelines
• Maintain thorough familiarity with protocols, case report forms, informed consent documents, source documentation, patient diaries, and study medications
• Adhere to GCP, ICH, HIPAA, NIH, and FDA regulations and maintain ongoing regulatory documents
• Demonstrate practical knowledge of document processes and reporting of SAEs, 1572s, CRFs, ICFs, and related regulatory documents
• Maintain accountability for ongoing professional growth and development
• Perform additional duties as assigned

Required Qualifications

• Master's degree
• Minimum 2 years of clinical experience
• Active license in good standing to practice as an advanced practice professional in the state of practice
• BLS/ACLS certification
• Proficiency with computer applications including Microsoft applications, email, electronic health records, and web applications
• Ability to type proficiently at 40+ words per minute
• Ability to perform basic clinical procedures including 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 with ability to work independently and collaboratively
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities
• Professional demeanor with respect for others, self-motivation, and 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 professionally in compliance with HIPAA guidelines

Preferred Qualifications

• Clinical research experience
• Bilingual proficiency in English and Spanish

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. Benefits include 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.