Sub Investigator (NP/PA-C) jobs in United States
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Hawthorne Health, Inc. · 10 hours ago

Sub Investigator (NP/PA-C)

Hawthorne Health is a leading community site network and home research visit solution provider. They are seeking a Nurse Practitioner (NP) or Certified Physicians Assistant (PA-C) to lead upcoming trials, assisting the Principal Investigator in managing clinical trials and ensuring participant safety.

Clinical TrialsHealth CareInformation Technology

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

Qualification

Nurse Practitioner (NP)Certified Physician Assistant (PA-C)ICH-GCP guidelinesFDA regulationsClinical trial management systemsElectronic data capture systemsClinical judgmentEthical conductPatient safetyInterpersonal skillsCommunication skillsProblem-solving abilitiesAttention to detailOrganizational skillsTime management

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, 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
Commitment to ethical conduct and patient safety

Preferred

Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus

Company

Hawthorne Health, Inc.

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Hawthorne Health is the leading community site network, with 75+ locations across the U.S. and a mission to make clinical trials more accessible.

Funding

Current Stage
Growth Stage
Total Funding
$23.1M
Key Investors
Northpond VenturesSignalFire
2021-06-09Series A· $20M
2019-09-01Convertible Note· $0.1M
2017-05-07Seed· $3M

Leadership Team

V
Valerie Burns
Product Manager
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Company data provided by crunchbase