Clinical Research Principal Investigator

5 days ago


San Bernardino, California, United States American Composites LLC Full time
About the Role

We are seeking a highly skilled and experienced Clinical Research Principal Investigator to join our team at American Composites LLC. As a Clinical Research Principal Investigator, you will be responsible for overseeing the conduct of clinical trials, ensuring the integrity and validity of the data obtained, and promoting adherence to standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and protocols.

Key Responsibilities
  • Attend site initiation visits and training sessions for all current protocols.
  • Maintain current licensure and complete required SOP training.
  • Oversee and provide guidance to clinical teams, ensuring delegated duties are performed within protocol, GCP, and federal regulated standards.
  • Assist in training of support staff for all clinical trials.
  • Recruit patients for clinical trials and refer to other site trials as necessary.
  • Set schedules to accommodate patients onsite and/or offsite, including weekends and holidays.
  • Conduct informed consent processes, evaluate patient eligibility, and collect medical and surgical history, concomitant medication use, and adverse events.
  • Document source documents, visit progress notes, adverse events, and maintain accurate records throughout.
  • Review lab results, provide clinical significance, and sign off on out-of-range or abnormal values.
  • Evaluate patient appropriateness for inclusion in trials, repeat labs as necessary, and counsel patients to seek medical care when appropriate.
  • Reinforce study restrictions, diets, and guidelines.
  • Review and sign off on CRFs, electronic CRFs, data clarification forms, and data queries upon completion.
  • Assess adverse events and drug reactions, thoroughly record details, and report serious adverse events to sponsors and IRBs.
  • Participate in monthly staff meetings and annual SOP meetings.
Requirements
  • Qualified person in the relevant field of healthcare (MD) with a minimum of 3 years of experience in clinical research.
  • Excellent communication, problem-solving, planning, and organizational skills.
  • Customer service skills and in-depth knowledge of FDA-GCP regulations.
  • Ability to work in a typical interior clinical/office environment, with occasional lifting of 20 pounds or more.
About American Composites LLC

American Composites LLC is a leading provider of innovative solutions in the field of clinical research. We are committed to improving the quality of life for millions of Americans through scientific research. Our team is dedicated to achieving efficiencies in the clinical trials sector, and we are seeking a highly skilled Clinical Research Principal Investigator to join our team.



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