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Lead Clinical Research Investigator

2 months ago

Secaucus, New Jersey, United States Frontage Laboratories Full time
Job Overview

Position Title: Principal Investigator

Reports To: Medical Director

Job Summary: As a Principal Investigator at Frontage Laboratories, you will be instrumental in spearheading and executing early-phase clinical trials aimed at assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of new investigational drugs. Your role will encompass the oversight and coordination of research activities to ensure adherence to regulatory standards, study protocols, and ethical guidelines.

Supervisory Responsibilities: You will provide leadership and direction to all clinical operations personnel involved in the execution of clinical study procedures.

Qualifications: A Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree along with a valid medical license in New Jersey is required.

  • Extensive experience in clinical research with a robust understanding of phase 1 clinical trial methodologies.
  • Comprehensive knowledge of regulatory frameworks, Good Clinical Practice (GCP) guidelines, and ethical standards governing human clinical trials.
  • Exceptional leadership, communication, and organizational capabilities.
  • Proven ability to collaborate effectively within a multidisciplinary team environment.
  • Strong analytical and problem-solving abilities.
  • Demonstrated capacity to manage multiple clinical studies concurrently.

Experience: A practicing physician with a minimum of 3 years of clinical research experience is essential. In-depth knowledge of FDA regulations related to Principal Investigator duties and safety reporting requirements is necessary, including treatment-emergent adverse events and serious adverse events. A solid understanding of Good Clinical Practices and ICH guidelines is also required.

Key Responsibilities:

Study Design and Planning:

  • Collaborate with the research team, sponsors, and regulatory bodies to design phase 1 clinical trials.
  • Develop and review study protocols, investigator brochures, and other pertinent documentation.

Regulatory Compliance:

  • Ensure all clinical trials conducted at the Phase 1 Unit meet relevant regulations, guidelines, and ethical standards.
  • Secure necessary approvals from regulatory agencies and ethics committees prior to study initiation.

Participant Safety and Informed Consent:

  • Protect the welfare of study participants by ensuring rigorous safety monitoring throughout the trial.
  • Obtain informed consent from all participants before their involvement in the clinical trial.

Study Conduct:

  • Oversee the screening of eligible participants for clinical trials.
  • Supervise the administration and monitoring of investigational drugs to participants.
  • Collaborate with medical staff and research personnel to ensure proper execution of the study.

Data Collection and Analysis:

  • Monitor and review the collection of accurate and reliable data during the trial.
  • Analyze and interpret trial results, contributing to scientific publications and regulatory submissions.

Communication and Reporting:

  • Maintain regular communication with sponsors, research staff, and stakeholders to provide updates on study progress.
  • Prepare and submit study reports to regulatory authorities and sponsors as required.

Quality Control and Assurance:

  • Implement quality control measures to uphold the integrity and accuracy of trial data.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and standard operating procedures (SOPs).

Training and Mentorship:

  • Provide guidance and mentorship to research staff involved in clinical trials.
  • Facilitate training sessions on study protocols, safety procedures, and relevant regulations.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with a disability.