Nurse Practitioner: Clinical Research

The Sub-Investigator (Sub-I) is a key member of the clinical research team, responsible for delivering safe, high-quality patient care and ensuring protocol integrity throughout clinical trials. This role includes daily phlebotomy and specimen handling, safety monitoring, data accuracy, and close collaboration with the Principal Investigator (PI) and study team.

• Perform comprehensive physical exams; review medical histories for eligibility and ongoing safety.
• Perform venipuncture daily; obtain, label, and process specimens (e.g., centrifuge, aliquot, prepare shipments) per protocol, SOPs, and chain-of-custody requirements.
• Place and manage IV lines when required by protocol; administer/oversee study medications and infusions per delegation and scope of practice.
• Interpret labs, vitals, ECGs, and other assessments; make sound clinical decisions and escalate to PI as needed.
• Proactively monitor patient safety before, during, and after interventions; identify, document, and report AEs/SAEs per FDA/ICH-GCP and sponsor timelines.
• Conduct informed consent; educate participants on procedures, risks, and visit schedules.
• Ensure data accuracy and completeness in EMR and EDC; maintain source documents and regulatory files in alignment with GCP, SOPs, and protocol.
• Lead or support quality checks of study data, specimen logs, and drug/device accountability; participate in CAPA activities when deviations occur.
• Collaborate with PI, coordinators, pharmacy, and lab to execute visit schedules and resolve issues quickly.
• Participate in investigator meetings, SIVs, monitoring visits, and audits/inspections.
• Stay current on protocol amendments, GCP, and site SOPs; contribute to process improvement.

• Licensed Nurse Practitioner or Physician Assistant (required).
• 2 years in clinical care or research; experience in clinical trials preferred.
• Demonstrated competency in phlebotomy (routine and difficult draws) and specimen processing in a regulated setting.
• Strong clinical judgment with strict adherence to patient safety practices.
• Exceptional attention to detail; proven accuracy in documentation, medication administration, and data entry.
• Familiarity with ICH-GCP, FDA regulations, IRB processes, and protocol compliance.
• Excellent communication and teamwork; able to educate patients and collaborate across disciplines.
• Comfort with EMR/EDC systems; proficient with Microsoft Office.

• Active, unrestricted NP or PA license (required).
• BLS (required); ACLS (preferred).
• Phlebotomy certification (preferred if not covered in clinical training); willingness to complete site competency assessment.

• Prior experience with investigational product administration and IV placement.
• Knowledge of sample handling requirements (temperature control, processing windows, shipping).
• Experience supporting audits/monitoring visits and implementing quality improvements.

• Fast-paced, patient-facing research clinic with cross-functional collaboration.
• Role involves standing, frequent blood draws, specimen processing, and occasional off-site visits.
• Commitment to quality, safety, and continuous improvement; participation in training and competency assessments required.