The Clinical Research Nurse Practitioner (NP) / Sub-Investigator plays a dual role in the clinical research setting, combining advanced clinical practice with protocol-directed research responsibilities. This role supports the Principal Investigator (PI) in conducting clinical trials in accordance with ICH-GCP guidelines, FDA regulations, and study protocols, while also delivering high-quality, patient-centered care to research participants.

This individual contributes to the success of clinical trials by overseeing safety, compliance, and data integrity throughout the study lifecycle, and plays a pivotal role in subject evaluation, treatment, and documentation.  This position reports to the Chief Medical Officer/Principal Investigator.

Principal Duties and Responsibilities (Essential Functions)

 Clinical Responsibilities

1. Perform comprehensive physical exams, medical histories, and clinical assessments on study participants.

2. Diagnose, manage, and treat study-related health concerns within the NP scope of practice.

3. Prescribe investigational and standard-of-care medications per protocol and state licensure.

4. Provide education and informed counseling to participants regarding protocols, medications, and procedures.

5. Monitor and respond to adverse events or serious adverse events (SAEs) in collaboration with the PI.

Research Responsibilities

1. Serve as a Sub-Investigator on designated clinical trials, assuming protocol-specific delegated tasks.

2. Conduct and document study visits according to protocol, including screening, enrollment, follow-up, and end-of-study visits.

3. Review and sign off on lab results, ECGs, imaging, and clinical assessments as required by the protocol.

4. Maintain accurate and complete source documentation and electronic data capture (EDC) records.

5. Ensure participant safety and protocol compliance through adherence to SOPs and regulatory standards.

6. Participate in site initiation visits (SIVs), monitoring visits, audits, and sponsor teleconferences as needed.

Operational and Team Support

1. Collaborate closely with clinical coordinators, regulatory staff, and data management teams.

2. Contribute to recruitment and retention strategies to meet enrollment targets.

3. Participate in continuous quality improvement and training efforts.

4. Assist in the development of SOPs, workflow enhancements, and protocol feasibility reviews.

5. Performs other duties as needed and/or assigned.

Job Specific (Minimum Requirements)

Knowledge, Skills, and Abilities

• Knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial operations.

• Exceptional interpersonal and communication skills.

• Strong clinical judgment and critical thinking ability.

• High attention to detail and commitment to accurate documentation.

• Proficient in electronic medical records (EMR), electronic data capture systems (EDC), and

  Microsoft Office Suite.

• Ability to multitask and manage competing priorities in a fast-paced research environment.

Education 

Masters or Doctorate in Nursing is Required

Experience

2 years in a Clinical setting as an NP is Required

2 years in Clinical Research is Preferred

1year as a Sub-Investigator or in a clinical research setting Preferred

Certifications and Licensures

Current Nurse Practitioner licensure in the state of Indiana is Required

National board certification in Family Practice, Adult-Gerontology, or relevant specialty is Required

DEA license (if applicable) is Required

Model of Care and Conduct

Methodist Hospitals strives for excellence and insists on high standards of conduct and performance in everything we do. Our Model of Care and Conduct is designed to create a positive work environment which Methodist desires for all employees. This is foundational to the high level of patient, family and physician satisfaction we strive for each day. As part of all position’s duties at Methodist Hospitals, all employees are responsible to conduct themselves in accordance with the Model of Care and Conduct and will be evaluated according to these standards of behavior.