PI Consultant for Community Trials (Remote, Part-Time)

Lever, Inc.; McAllen (TX); Hybrid; USD 138,000 - 344,000; Part time

Job summary

Hawthorne Health seeks an experienced Principal Investigator MD for a part-time, 1099 contract to lead the investigation for a new site in McAllen, TX. The PI will oversee on-site and remote clinical oversight, ensuring adherence to protocol, GCP, and regulatory standards.

Responsibilities include supervising the research team, coordinating with sponsors and CROs, reviewing safety data, and ensuring compliant data collection.

Qualifications

• Experience as a Principal Investigator on at least 3 sponsor initiated clinical trials.
• Medical Doctor (M.D.) degree from an accredited institution.
• Current, unrestricted medical license.
• Board certification in a relevant specialty preferred.
• Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and regulatory requirements for clinical research.

Responsibilities

• Accurately document findings and contribute to trials, registries, or research protocols.
• Oversee and manage all aspects of clinical trials at the site, ensuring GCP/ICH compliance.
• Lead and supervise the clinical research team, including sub-investigators and staff.
• Delegate duties and ensure proper training and oversight.
• Remote review of patient assessments to ensure appropriate enrollment.
• Review laboratory results, ECGs, and other diagnostics.
• Make medical decisions regarding participant care and protocol deviations.
• Ensure accurate, complete, and timely data collection and documentation.
• Communicate with sponsors, CROs, IRBs, and regulators.
• Manage investigational product accountability per protocol.
• Participate in site initiation, monitoring visits, audits, and inspections.
• Maintain ongoing medical education and stay current with research advances.

Skills

PI leadership

GCP knowledge

FDA knowledge

Clinical oversight

English communication

Team management

Education

MD degree

Job description

Hawthorne Health seeks an experienced Principal Investigator MD for a part-time, 1099 contract to lead the investigation for a new site in McAllen, TX. The PI will oversee on-site and remote clinical oversight, ensuring adherence to protocol, GCP, and regulatory standards.

Responsibilities include supervising the research team, coordinating with sponsors and CROs, reviewing safety data, and ensuring compliant data collection.