Nurse Practitioner

Job Description

Job Title: Nurse Practitioner – Clinical Research Clinician (obesity and fatty liver / Phase III Trial)
Reports to: Principal Investigator (PI) / Site Medical Director
Location: Clinical Research Center (in-clinic + some remote visits)

Position Summary

The Nurse Practitioner (NP) will provide direct clinical care to participants enrolled in a long-term, Phase III, randomized, double-blind clinical trial of once-weekly meds vs placebo in adults with MASH and fibrosis stage F2–F3.

Working under the supervision of the Principal Investigator and within the NP’s legal scope of practice, the NP will:

• Conduct screening and randomisation visits
• Perform protocol-required assessments per the Schedule of Assessments (SoA)
• Monitor participant safety and manage adverse events
• Support investigational product (IP) use and adherence
• Ensure high-quality, ALCOA-compliant source documentation and eCRF data entry

This role is suitable for an experienced NP or a motivated NP new to research who is a fast learner with strong communication skills.

Key Responsibilities

1. Screening & Eligibility

• Obtain and document informed consent (main study and any applicable sub-studies as per site processes).
• Collect comprehensive medical history, including:
• • Liver-related history and procedures
  • Cardiometabolic conditions (T2DM, hypertension, dyslipidaemia, obesity)
  • Psychiatric history, cancer history, and other key conditions referenced in inclusion/exclusion criteria.
• Perform a complete physical exam at screening per protocol (general, cardiovascular, pulmonary, abdominal, extremities, skin, etc.).
• calculate BMI and obesity stage.
• Order and/or coordinate protocol-required procedures and labs (central labs, ECG, imaging, liver biopsy, ophthalmology, etc.).
• Review all screening data with the PI and confirm inclusion/exclusion status before randomisation.

2. Randomisation Visit (Visit
2) – Mandatory Same-Day Medical History

On the day of randomisation, the NP must:

• Perform and document an updated medical history focused on:
• • Any new diagnoses, hospitalizations, surgeries, or ED visits since screening
  • Any new or changed medications (including OTC and herbal)
  • Any new symptoms or relevant events
• Clearly document, in ALCOA-compliant source:
• • “No interval changes since screening” or
  • “Interval changes since screening:” with full details
• Confirm that no new condition or medication has emerged that would violate inclusion/exclusion criteria, and escalate to PI if there is any doubt.

This interval medical history on the randomisation day is mandatory for every participant before the first dose is administered.

3. In-Clinic Follow-Up Visits

At each in-clinic visit, the NP will:

• Obtain interval history (new symptoms, hospitalizations, procedures).
• Review concomitant medications and document changes, especially:
• • Antihypertensives
  • Lipid-lowering agents
  • Anti-hyperglycemic medications
• Measure and document:
• • Vital signs (BP, pulse) after adequate rest
  • Weight and, when required, waist/hip circumference
• Perform targeted or complete physical exams per visit requirements.
• Coordinate ECGs, labs, imaging, liver biopsies, and other tests as required by the SoA.
• Assess tolerability and check for injection site reactions.
• Provide education and reinforcement on:
• • IP self-administration (pre-filled syringe)
  • Fasting instructions and visit preparation
  • Diet and physical activity counselling (per protocol and site SOPs).

4. Remote / Telephone Visits

For designated remote visits, the NP will:

• Conduct a structured telehealth assessment:
• • Interval events (hospitalizations, new diagnoses)
  • Symptoms, AEs/SAEs/AESIs
  • Medication changes
• Guide the participant in completing any required ePROs or questionnaires.
• Document the remote encounter in ALCOA-compliant source and ensure timely eCRF entry.

5. Safety Monitoring (AEs, SAEs, AESIs)

• Actively screen at each contact for:
• • Adverse events (AEs), Serious AEs, and Adverse Events of Special Interest (AESIs)
  • Liver-related events, pancreatitis, gallbladder events, cardiovascular events, psychiatric events, and other protocol-specified AESIs.
• Apply protocol algorithms for:
• • Elevated liver enzymes / suspected DILI
  • QTc prolongation or other significant ECG findings
  • Sui…