Sub Investigator - Nurse Practitioner - Tucson, AZ

Iterative Health•Tucson, AZ

19h•Onsite

About The Position

Iterative Health is a healthcare technology and services company focused on accelerating clinical research. They have established a network of over 100 sites globally, specializing in gastrointestinal, hepatology, obesity, and cardiology research. By integrating clinical trial expertise with AI, Iterative Health connects sponsors with high-performing research teams to improve patient access to new treatments. The company has offices in Cambridge, MA, and New York City, with over 250 employees worldwide. This role of Sub Investigator - Nurse Practitioner is a hybrid position combining advanced clinical practice with clinical research. The Nurse Practitioner will function as a delegated Sub-Investigator, working under the supervision of the Principal Investigator on multiple studies. Responsibilities include conducting medical histories, physical exams, evaluating participant eligibility, managing participant safety, and ensuring protocol adherence. The role also involves mentoring research coordinators and staff to foster a strong site research culture.

Requirements

Current unrestricted Nurse Practitioner license in the applicable state.
Minimum 3 years of clinical research experience strongly preferred.
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

Nice To Haves

DEA preferred
Cardiovascular clinical experience preferred, or demonstrated willingness to develop expertise in the applicable therapeutic area.
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.

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.
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.