Nurse Practitioner
hace 3 días
Miami
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 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, • Suicidal ideation (C-SSRS) or PHQ-9 score thresholds, • Worsening diabetic retinopathy, significant renal changes, or severe GI events, • Immediately escalate significant safety issues to the PI and follow sponsor reporting timelines for SAEs and AESIs. 6. Documentation & ALCOA Requirements The NP is responsible for ensuring that all trial documentation strictly follows ALCOA principles: • Attributable – Every entry must clearly show who entered it and when (initials/signature, date, and time if applicable)., • Legible – Notes must be readable by monitors, auditors, and regulators., • Contemporaneous – Document as close as possible to the time the activity occurred; avoid “back-dating.”, • Original – Preserve original source documents (paper or validated electronic); clearly identify copies and ensure they match the original., • Accurate – Data must be correct, consistent with the protocol and source evidence, and free of uncontrolled changes. 7. Data Entry & Query Resolution • Enter data into the eCRF accurately and within agreed timelines.( medical hx), • Respond promptly and clearly to monitor or data-management queries., • Licensed Nurse Practitioner (FNP, AGNP, Internal Medicine NP, or equivalent) in good standing., • Strong clinical foundation in internal medicine, hepatology, endocrinology, cardiometabolic disease, or primary care., • Demonstrated ability to:, • Perform and document comprehensive histories and physicals, • Interpret basic labs and ECGs, • Prior clinical research experience is preferred, but not strictly required., • Excellent written and verbal communication for both clinical documentation and participant education. If you are an NP without prior clinical experience in the United States (e.g., newly relocated or primarily trained/practiced abroad), please only apply if: • You are a very fast learner, comfortable mastering detailed protocols and U.S. documentation standards quickly, and, • You have exceptional communication skills with patients, including the ability to:, • Explain complex information in clear, compassionate language, • Build trust across different cultures and literacy levels, • Navigate sensitive topics (liver disease, weight, mental health) with empathy and professionalism
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