Nurse Practitioner Or Sub-Investigator

Overview

• Serve as a Sub-Investigator in clinical research studies, supporting the Principal Investigator (PI) with medical assessments and subject management.
• Perform physical exams, medical history reviews, and protocol procedures to ensure compliance with research guidelines.
• Coordinate daily clinical research activities following GCP, FDA, and ICH guidelines.
• Educate patients and families about treatments, side effects, and study protocols.
• Participate in study-specific training, site initiation visits, and investigator meetings.
• Maintain strict confidentiality and adhere to HIPAA guidelines in all operations.
• Collaborate with sponsors, patients, and staff to ensure high-quality study outcomes.
• Support process improvement and change management initiatives within the site.
• Assist in training and mentoring new staff on study-specific tasks.

Key Responsibilities & Duties

• Act as Sub-Investigator, ensuring IRB-approved protocols are implemented and followed accurately.
• Execute informed consent processes and monitor patient safety and status throughout the study.
• Perform clinical procedures such as injections, IVs, and assessments of vital signs and laboratory results.
• Mix and dispense investigational products, providing instructions on usage and drug interactions.
• Participate in pre-study visits, site initiation visits, and investigator meetings as required.
• Ensure proper documentation and reporting of SAEs, 1572s, CRFs, and ICFs.
• Maintain regulatory compliance with GCP, ICH, HIPAA, NIH, and FDA standards.
• Support site management in process improvement and staff training initiatives.
• Establish rapport with sponsors, patients, and staff to facilitate effective communication.

Job Requirements

• Bachelor’s degree in a relevant field and minimum of 2 years of clinical experience.
• Active license to practice as an advanced practice professional in the state of practice.
• Proficiency with Microsoft applications, electronic health records, and web applications.
• Ability to perform clinical procedures such as vitals, EKGs, phlebotomy, and IVs.
• Strong organizational skills and attention to detail in managing study protocols.
• Excellent written and verbal communication skills for patient and sponsor interactions.
• Ability to handle sensitive information confidentially and professionally.
• Experience in clinical research coordination is preferred but not required.
• Bi-lingual proficiency in English and Spanish is a plus.