Principal Investigator (MD/DO) - Respiratory Clinical Trials

Hawthorne Health; Gadsden (AL); Presencial; USD 207.000 - 344.000; Jornada completa

Descripción de la vacante

Lever, Inc. is seeking an MD with proven leadership to manage on-site clinical trials, ensuring adherence to protocol, GCP, and regulatory requirements.

You will supervise sub-investigators and study staff, oversee patient assessments, data integrity, and safety monitoring, and communicate with sponsors and IRBs. Key responsibilities include site initiation, monitoring visits, audits, and staying current with clinical research developments in respiratory indications.

Formación

• MD with current, unrestricted license and leadership of at least three sponsor-initiated trials as PI or Sub-I.
• Deep knowledge of FDA regulations, ICH-GCP guidelines, and ethics in clinical research.
• Experience leading respiratory-indication trials and clinical teams.
• Strong leadership, organizational, and communication skills.

Responsabilidades

• Accurately document findings and contribute to trials, registries, or research protocols.
• Oversee all site trial activities ensuring protocol and GCP adherence.
• Lead and supervise the clinical research team.
• Delegate duties to qualified personnel with proper training.
• Conduct remote review of patient assessments to ensure enrollment.
• Review lab results, ECGs, and other diagnostics.
• Make medical decisions on participant care and protocol deviations.
• Ensure complete and timely collection of study data.
• Communicate with sponsors, CROs, IRBs, and regulators.
• Manage investigational product accountability with IP team.
• Participate in site initiation, monitoring visits, audits, inspections.
• Maintain ongoing medical education and stay current in the field.

Conocimientos

Leadership

Clinical oversight

Regulatory knowledge

Medical judgment

Educación

MD degree

Medical license

Descripción del empleo

Responsibilities

• Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable.
• Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
• Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff.
• Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight.
• Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment.
• Review and interpret laboratory results, ECGs, and other diagnostic tests.
• Make critical 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 sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
• Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team.
• Participate in site initiation visits, monitoring visits, audits, and inspections.
• Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.

Requirements

• Must be an MD with experience leading at least three sponsor initiated trials as a PI or Sub-I.
• Current, unrestricted medical license.
• Experience with respiratory indications in clinical trials and/or in a clinical setting.
• Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research.
• Proven leadership and team management skills.
• Excellent clinical judgment and decision-making abilities.
• Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely.
• Exceptional organizational skills and meticulous attention to detail.
• Ability to manage multiple complex studies simultaneously and prioritize tasks effectively.
• Commitment to ethical conduct and patient safety.

Location

• This role requires on-site presence approximately twice to four times per month for key visits (or more, depending on study needs), with additional oversight responsibilities performed remotely (approximately 3–5 hours per week).
• Preference is for Investigator to live within 1.5 hours driving distance of the site.

$150 - $250 an hour