Lead Clinical Investigator (MD/DO)

System One; Pittsburgh (Allegheny County); Presencial; USD 140.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and welfare benefits

401(k) plan

Descripción de la vacante

System One is seeking an experienced Principal Investigator (MD/DO) to lead medical oversight for a new clinical research site in Pittsburgh, PA. The role involves reviewing eligibility, overseeing safety and data quality, and guiding clinical staff across trials.

The position requires an active Pennsylvania medical license and PI or Sub-Investigator experience, with a strong focus on patient safety and regulatory compliance. Join a team dedicated to high-quality, patient-centered research.

Formación

• MD or DO with Internal Medicine, Family Medicine, or a Specialty.
• Active, unrestricted Pennsylvania medical license.
• Prior PI or Sub-Investigator clinical research experience.
• Strong clinical judgment and participant safety focus.
• Familiarity with ICH-GCP and FDA regulations.
• Board certification.
• DEA registration if required by study protocols.
• Excellent communication and documentation skills.

Responsabilidades

• Provide medical oversight and clinical leadership for assigned clinical trials, ensuring patient safety and data quality.
• Serve as the study physician, reviewing participant eligibility and providing medical oversight of screening outcomes.
• Review adverse events (AEs), serious adverse events (SAEs), and participant safety trends.
• Perform or oversee study-specific medical assessments, including histories, physical exams, and endpoint assessments.
• Offer clinical guidance and oversight to Sub-Investigators, Clinical Research Coordinators, RNs, and site staff.
• Collaborate with study sponsors, CROs, IRBs, and company leadership throughout each trial.
• Participate in site initiation visits, monitoring visits, close-out activities, and other study meetings.
• Review clinical data such as laboratory results, ECGs, vital signs, and other assessments.
• Support timely safety reporting, medical documentation, and resolution of clinical data queries.
• Maintain compliance with study protocols, SOPs, ICH-GCP, FDA regulations, and state requirements.
• Contribute to a culture of quality, continuous improvement, and patient-centered research.

Conocimientos

Clinical judgment

Participant safety

Communication

Documentation

ICH-GCP familiarity

FDA regulations

Confidentiality

Educación

MD/DO

Board certification

Descripción del empleo

System One is seeking an experienced Principal Investigator (MD/DO) to lead medical oversight for a new clinical research site in Pittsburgh, PA. The role involves reviewing eligibility, overseeing safety and data quality, and guiding clinical staff across trials.

The position requires an active Pennsylvania medical license and PI or Sub-Investigator experience, with a strong focus on patient safety and regulatory compliance. Join a team dedicated to high-quality, patient-centered research.