Part-Time Dermatology Principal Investigator for Trials

Hawthorne Health; Springfield (MO); Sur place; USD 207 000 - 344 000; Temps partiel

Résumé du poste

Hawthorne Health seeks an experienced Principal Investigator (MD/DO) for a part-time, 1099 role to lead Dermatology trials across a community-based site network. The PI will oversee study conduct, data integrity, and regulatory compliance, with on-site presence and remote oversight.

Prior PI/Sub-I experience on sponsor-initiated trials is required, along with an active medical license and strong leadership skills.

Qualifications

• MD with leadership of at least three sponsor-initiated trials as PI or Sub-I.
• Current, unrestricted medical license.
• Dermatology trial experience.
• Deep knowledge of ICH-GCP and FDA regulations.
• Strong leadership and communication skills.

Responsabilités

• 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.

Connaissances

PI/Sub-I leadership

Regulatory knowledge

Clinical trial oversight

Team leadership

Excellent English communication

Formation

MD degree

Description du poste

Hawthorne Health seeks an experienced Principal Investigator (MD/DO) for a part-time, 1099 role to lead Dermatology trials across a community-based site network. The PI will oversee study conduct, data integrity, and regulatory compliance, with on-site presence and remote oversight.

Prior PI/Sub-I experience on sponsor-initiated trials is required, along with an active medical license and strong leadership skills.