Clinical Research Sub-Investigator Nurse Practitioner

Iterative Health; New Albany (IN); Hybrid; USD 90,000 - 125,000; Full time

Job summary

Iterative Health in New Albany, Indiana, seeks a licensed Nurse Practitioner to serve as a delegated Sub-Investigator across active clinical studies. You will conduct histories, exams, screen participants, and monitor safety under PI supervision, while mentoring CRCs and staff to maintain protocol integrity and sponsor confidence.

You will ensure compliance with FDA/ICH-GCP, HIPAA, and state regulations, document thoroughly, and advance patient safety and study quality in a fast-paced,

Qualifications

• Current unrestricted Nurse Practitioner license in the applicable state.
• Active or pending DEA registration preferred.
• Minimum 3 years of clinical research experience strongly preferred.
• Cardiovascular clinical experience preferred, or demonstrated willingness to develop expertise.
• Ability to work independently with strong problem-solving and communication skills.

Responsibilities

• Serve as a delegated Sub-Investigator on clinical research studies under the supervision of the Principal Investigator, as documented on the study Delegation of Authority Log.
• Conduct comprehensive medical histories and perform protocol-required physical examinations, including screening, baseline, interim, and end-of-study assessments.
• Evaluate potential study participants to determine eligibility based on protocol inclusion and exclusion criteria.
• Conduct informed consent discussions and obtain informed consent when delegated by the PI and permitted by protocol and applicable regulations.
• Provide ongoing clinical care and medical oversight for research participants throughout study participation.
• Monitor participant safety by evaluating adverse events (AEs), serious adverse events (SAEs), abnormal test results, and concomitant medications; elevate concerns to the PI as appropriate.
• Order, review, interpret, and sign protocol-required clinical assessments, laboratory reports, ECGs, imaging studies, pathology reports, and procedure results as delegated by the PI.
• Prescribe study-related medications and other medically necessary treatments in accordance with study protocols, state law, and scope of practice.
• Maintain accurate, complete, and timely clinical documentation in source records, electronic medical records (EMR), and electronic data capture (EDC) systems.
• Ensure protocol-required procedures, assessments, and visits are completed accurately and in accordance with sponsor requirements and GCP.
• Review and complete medical documentation, source documentation, and study-related clinical assessments as delegated by the PI.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA, sponsor requirements, and all applicable federal, state, and local regulations.
• Maintain current licensure, national certification, DEA registration (if applicable), required clinical research training, and continuing education.
• Collaborate with Principal Investigators, CRCs, sponsors, monitors, and other members of the research team to ensure successful study execution and participant safety.
• Participate in protocol feasibility assessments, site initiation visits, monitoring visits, sponsor audits, and regulatory inspections.
• Assist in the implementation of new clinical trials by reviewing protocols, identifying clinical requirements, and supporting study start-up activities.
• Provide clinical guidance and mentorship to CRCs and other research staff regarding protocol requirements, participant safety, and study procedures.
• Performs related duties

Skills

Nurse Practitioner license

Clinical research experience

EDC/EMR familiarity

Communication skills

Problem solving

Mentorship/leadership

Tools

EMR systems

EDC platforms

Office software

Job description

Iterative Health in New Albany, Indiana, seeks a licensed Nurse Practitioner to serve as a delegated Sub-Investigator across active clinical studies. You will conduct histories, exams, screen participants, and monitor safety under PI supervision, while mentoring CRCs and staff to maintain protocol integrity and sponsor confidence.

You will ensure compliance with FDA/ICH-GCP, HIPAA, and state regulations, document thoroughly, and advance patient safety and study quality in a fast-paced,