Sub Investigator - Nurse Practitioner - New Albany, IN

Where You'll Drive Impact

• 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with the PI, whether participants may continue study participation, require additional monitoring, or should be withdrawn for safety or protocol-related reasons.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.
• Performs related duties

What You Bring to the Team

• 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 life 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.

Additional information

At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact.