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Hawthorne Health

Posted 5 months ago

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Sub Investigator (NP/PA-C) - Gadsden, Alabama

Gadsden, ALOn-siteFull-time

AI Summary

Sub Investigator (NP/PA-C) assisting the Principal Investigator in overseeing and managing clinical trials at a community research site, ensuring protocol adherence, participant safety, and accurate data collection.

About this role

About Us
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. Hawthorne leverages convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients. Our community-based model shortens timelines and helps bring better treatments to market, faster.

About the Role
Hawthorne Health is seeking a Nurse Practitioner (NP) or Certified Physicians Assistant (PA-C) with experience supporting sponsor initiated trials as a Principal or Sub-Investigator to lead upcoming trials at our site in Gadsden, Alabama.

Responsibilities

  • Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
  • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI.
  • Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings.
  • Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision.
  • Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations.
  • Ensure accurate, complete, and timely collection and documentation of all study data.
  • Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
  • Assist with investigational product accountability, storage, and administration according to protocol.
  • Participate in site initiation visits, monitoring visits, audits, and inspections as required.
  • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.

    • Requirements

  • Must be a NP or PA-C able to work with adult and pediatric patients.
  • Experience working on at least 3 sponsor initiated clinical trials as a Sub Investigator.
  • Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research.
  • Strong interpersonal and communication skills, with the ability to work effectively as part of a team.
  • Excellent clinical judgment and problem-solving abilities.
  • Meticulous attention to detail and strong organizational skills.
  • Ability to prioritize tasks and manage time efficiently.
  • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus.
  • Commitment to ethical conduct and patient safety.

    • Skills

    Adverse Event ReportingCTMSElectronic Data Capture (EDC)Eligibility ScreeningFDA RegulationsICH-GCPNPPA-CSponsor-initiated TrialsSub-investigator

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