Principal Investigator

About the role

As a Principal Investigator, you will lead and oversee clinical investigation protocols, ensuring adherence to FDA regulations and GCP/ICH guidelines. You will manage the medical care of research subjects, protect their rights and welfare, and ensure the validity and documentation of trial data.

Responsibilities

• Complete required training, including GCP and IATA.
• Maintain a working knowledge of FDA regulations, GCP/ICH guidelines, SOPs, and study protocols.
• Keep an up-to-date curriculum vitae and current licensure to practice.
• Assume responsibility for clinical investigation protocols.
• Understand the requirements of each protocol thoroughly.
• Determine adequate resources for conducting research protocols.
• Manage the medical care of subjects and protect their rights and welfare.
• Ensure validity of trial data reported to sponsors.
• Document study-related procedures, processes, and events.
• Ensure proper use and storage of Investigational Products.
• Attend investigator meetings as necessary.
• Assist with creating PI oversight plans for studies.
• Conduct and oversee staff training.
• Conduct patient consent discussions, ensuring understanding of procedures, risks, benefits, and alternatives.
• Provide clear explanations of study protocols and ensure patient understanding before obtaining consent.
• Facilitate effective communication between patients, healthcare providers, and research staff.

Requirements

• Clinical research expertise.
• Experience with Phase I clinical trials.
• Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) with an active medical license.
• Compliance with clinical trial regulations.

Qualifications

• Minimum 2 years of experience as a Research Investigator.
• Board certification or eligibility in a relevant specialty.
• Training and certification in SOPs, and Good Clinical Practice (GCP).

Work Environment

This position requires onsite work, ensuring direct engagement with research activities and protocols.

Pay and Benefits

The pay range for this position is $270,400.00 - $312,000.00/yr. The company offers competitive pay and benefits, and rewards high performance with excellent career opportunities.

Schedule

This is a Permanent position based out of Houston, TX, and is a fully onsite position.