The Role
The Sub Investigator assists the Principal Investigator in managing clinical trials, ensuring protocol adherence, participant safety, and accurate data collection.
Summary Generated by Built In
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 McAllen, TX.
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.
Hawthorne Health is transforming the clinical trial landscape through an innovative site model that integrates research into community-based settings like local pharmacies. By meeting patients where they already receive care, we are improving access, strengthening trust, and driving more inclusive and efficient trials.
We welcome the opportunity to connect with individuals interested in being part of this evolving mode
Skills Required
- 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 and FDA regulations
- Strong interpersonal and communication skills
- Excellent clinical judgment and problem-solving abilities
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The Company
What We Do
Hawthorne Health is a clinical trial platform and community site network that integrates technology and medical professionals to make clinical trials more accessible, inclusive, and patient-centric. They operate across the U.S., supporting various therapeutic areas by embedding research in local communities and offering decentralized trial services to reduce barriers to participation, improve retention, and drive faster, more cost-effective research outcomes for study sponsors.
