Sub Investigator - Nurse Practitioner - Tucson, AZ

About the role

As a Sub Investigator-Nurse Practitioner at Iterative Health, this role sits at the intersection of advanced clinical practice and clinical research, serving as a delegated Sub-Investigator under the supervision of the Principal Investigator across multiple active studies.

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.
• Determine, in collaboration with the PI, whether participants may continue study participation, require additional monitoring, or should be withdrawn for safety or protocol-related reasons.
• Provide ongoing clinical care and medical oversight for research participants throughout study participation.
• Assess, diagnose, and manage participant health concerns within the scope of licensure and delegated authority.
• Monitor participant safety by evaluating adverse events (AEs), serious adverse events (SAEs), abnormal test results, and concomitant medications; escalate 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.
• Aid 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.

Requirements

• Current unrestricted Nurse Practitioner license in the applicable state.
• DEA preferred.
• Minimum 3 years of clinical research experience, strongly preferred.
• Cardiovascular clinical experience preferred, or demonstrated willingness to develop expertise in the applicable therapeutic area.
• Strong ability to own issues and problem-solve independently.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Proficiency in standard office software, EMR, and EDC platforms.
• Highly organized with the ability to manage multiple priorities in a fast-paced, protocol-driven environment.
• Must be able to lift 25 lbs.

Preferred Qualifications

• Familiarity with GCP guidelines, FDA regulations, and ICH standards governing clinical research.
• ACRP or SOCRA certification (CCRC or CCRP), or active pursuit of certification, strongly preferred.
• DEA registration or eligibility.
• Experience working within a multi-site clinical research network or sponsor-facing environment.