Principal Investigator (3220)

The Principal Investigator (MD) is accountable and responsible for ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of subject generated data and directing the conduct of research according to federal and state regulations and guidance documents.

DUTIES & RESPONSIBILITIES

• Completing DMCR-required training, including GCP and IATA.
• Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Maintaining a current, up-to-date curriculum vitae and current licensure to practice.
• Assuming responsibility for the conduct of clinical investigation protocols.
• Possessing a thorough understanding of the requirements of each protocol.
• Determining adequate resources available to conduct research protocols.
• Managing the medical care of subjects; protecting the rights and welfare of subjects.
• Ensuring the validity of the trial data reported to the sponsor.
• Ensuring documentation of study-related procedures, processes, and events.
• Ensuring the proper use and storage of Investigational Products.
• Attending investigator meetings as necessary for study participation.
• Assist with creating PI oversight plans for every study.
• Conduct and oversee ongoing staff training.
• Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives 
• Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent 
• Facilitate effective communication between patients, healthcare providers, and research staff
• Any other matters as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

• Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted). 

Experience:

• At least 2 years of experience as a Clinical Research Investigator

Credentials:

• Medical licensure (license must be valid in the state in which the research is conducted).
• Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
• Training and certification in DMCR required training and Standard Operating Procedures (SOP’s).
• Training and certification in Good Clinical Practice (GCP)

Knowledge and Skills:

• Proficient communication and comprehension skills both verbal and written in the English language are required. 
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.