Principal Investigator Clinical Trials (FT PI-MD/DO)

Principal Investigator

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase IIV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

The Principal Investigator ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. This role is PT, 20 hours per week.

Responsibilities:

• Work with the Site Director and Medical Director to provide oversight of Sub-Investigator. Review work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements.
• Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment.
• Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies.
• Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study.
• Maintain a current, up to date curriculum vitae.
• Maintain current licensure to practice.
• Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so.
• Assess subject compliance with the test article and follow-up visits.
• Assess subject's response to therapy.
• Evaluate for adverse experiences per protocol guidelines.
• Provide new information about the study or test article(s)
• Document deviations from the approved protocol
• Document and explain premature unblinding of the investigational product(s)
• Thoroughly familiar with the use of the investigational product(s)
• Communicate effectively with subjects, research team, IRB, and sponsor.

Skills and Qualifications:

• Education and experience
  • M.D, D.O., or PhD required.
• Requirements
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology to communicate with physician office and laboratory staff.
  • Skilled in working with potential sponsors to place research with the site.
  • Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment.
  • Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirements.
  • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
  • Experienced negotiation skills
  • Formal presentation skills
  • Ability to perform overnight business travel.
  • Excellent persuasive/selling skills.
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)