Pulmonologist - Clinical Research Investigator

Elite Clinical Network; San Jose (CA); Sur place; USD 90 000 - 140 000; Temps partiel

Résumé du poste

A clinical research organization is searching for a dedicated Physician – Pulmonologist for a part-time role in San Jose, California. The successful candidate will act as a Principal Investigator or Sub-Investigator on clinical trials, ensuring high-quality medical care to adult patients in a research setting. Key responsibilities include evaluating patient eligibility, overseeing trial participants, and maintaining documentation. Candidates must possess an MD or DO degree, a valid medical license, and a commitment to GCP standards.

Qualifications

• Minimum of 1 year of experience in clinical practice.
• Current Good Clinical Practice (GCP) certification or willingness to obtain.
• Board Certified or Board Eligible in Pulmonology.
• BC/BE in Family Medicine or Geriatric Medicine also considered.
• Current GCP certification or willingness to obtain prior to start.
• Minimum of 1 year of clinical practice; prior clinical research preferred but not required.

Responsabilités

• Serve as Principal Investigator or Sub-Investigator on clinical trials.
• Perform physical exams and clinical assessments for protocol eligibility.
• Provide medical oversight and evaluate safety for study participants.
• Provide medical oversight, safety assessments, and ongoing care for participants.
• Collaborate with coordinators, sponsors, and monitors to ensure protocol compliance and data integrity.
• Sign off on source documents, CRFs, and regulatory documents.
• Maintain accurate trial documentation per ICH-GCP, FDA, and sponsor requirements.
• Participate in Site Initiation Visits, Monitoring Visits, and Audits as needed.
• Manage chronic and acute conditions per protocol guidelines.
• Educate and counsel patients on study procedures and informed consent.
• Support recruitment and retention efforts in trials.

Connaissances

Familiarity with FDA regulations

Interpersonal and communication skills

Attention to detail

Electronic medical records (EMRs)

Clinical trial management systems (CTMS)

EMRs usage

CTMS usage

Formation

MD or DO degree from an accredited medical school

Valid medical license in the state of employment

Board Certified or Board Eligible in Pulmonology

GCP certification or willingness to obtain

Outils

EMRs

CTMS

Description du poste

Position Overview

Elite Clinical Network (ECN) is seeking a dedicated and research-oriented Physician – Pulmonologist to join our expanding team of clinical professionals. The ideal candidate will play a critical role in the conduct of clinical trials by serving as a Principal Investigator (PI) or Sub-Investigator, while continuing to provide high-quality medical care to adult patients within a clinical research setting. This is a part-time/per diem position with a unique opportunity to contribute to the advancement of medicine through clinical studies.

Key Responsibilities

• Serve as Principal Investigator or Sub-Investigator on multiple Phase I–IV clinical trials.
• Perform comprehensive physical exams and clinical assessments for protocol screening and enrollment.
• Evaluate patient eligibility based on inclusion/exclusion criteria of clinical protocols.
• Provide medical oversight for clinical trial participants, including safety assessments, adverse event evaluations, and ongoing care.
• Collaborate closely with Clinical Research Coordinators, Sponsors, and Monitors to ensure protocol compliance and data integrity.
• Review and sign off on source documents, case report forms (CRFs), and regulatory documentation.
• Maintain detailed and accurate clinical trial documentation in compliance with ICH-GCP, FDA, and sponsor requirements.
• Participate in Site Initiation Visits (SIVs), Monitoring Visits, and Audits as needed.
• Manage chronic and acute conditions among study participants in alignment with standard care and protocol guidelines.
• Educate and counsel patients on study procedures, informed consent, and potential side effects.
• Support recruitment efforts and promote patient retention in trials.

Qualifications

• MD or DO degree from an accredited medical school.
• Valid, unrestricted medical license in the state of employment.
• Board Certified or Board Eligible (BC/BE) in Pulmonology.
• BC/BE in Family Medicine or Geriatric Medicine will also be considered.
• Current Good Clinical Practice (GCP) certification or willingness to obtain prior to start.
• Minimum of 1 year of experience in clinical practice; prior clinical research experience preferred but not required.

Preferred Skills

• Familiarity with FDA, ICH-GCP, and clinical trial protocols.
• Experience managing or participating in industry-sponsored clinical trials.
• Strong attention to detail and ability to document accurately.
• Excellent interpersonal and communication skills for patient interaction and sponsor collaboration.
• Ability to work collaboratively with a cross-functional team in a fast-paced research environment.
• Comfortable using electronic medical records (EMRs) and clinical trial management systems (CTMS).
• DEA license (preferred).

Seniority Level

Mid-Senior level

Employment Type

Part-time

Job Function

Strategy/Planning and Information Technology