healthcare
Posted 7 hours agoSub Investigator - Nurse Practitioner - Tucson, AZ
Tucson, United StatesOn-site
Responsibilities
- Conduct comprehensive medical histories and perform protocol-required physical examinations, including screening, baseline, interim, and end-of-study assessments.
- Conduct informed consent discussions and obtain informed consent when delegated by the PI and permitted by protocol and applicable regulations.
- 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.
- 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.
Requirements
- By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need.
- The ideal candidate is a licensed Nurse Practitioner with at least three years of clinical research experience, a strong patient-first mindset, and the clinical judgment to navigate complex, protocol-driven environments with confidence.
- Current unrestricted Nurse Practitioner license in the applicable state. DEA preferred
- Strong ability to own issues and problem-solve independently.
- 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.
- 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.
- Experience working within a multi-site clinical research network or sponsor-facing environment.
Experience
- Minimum 3 years of clinical research experience strongly preferred.
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
- We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology.
- Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
- 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.
- You will bring your full clinical capabilities conducting medical histories and physical exams, evaluating eligibility, managing participant safety, and ensuring every protocol-required procedure is executed with precision and care.
- Beyond the clinical work, you'll serve as a mentor and resource for CRCs and research staff, helping build the kind of site-level research culture that earns the confidence of sponsors, patients, and investigators alike.
- 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.
- Evaluate potential study participants to determine eligibility based on protocol inclusion and exclusion criteria.
- Provide ongoing clinical care and medical oversight for research participants throughout study participation.
- Order, review, interpret, and sign protocol-required clinical assessments, laboratory reports, ECGs, imaging studies, pathology reports, and procedure results as delegated by the PI.