The Principal Investigator 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.
Skills Required
- M.D. or D.O. degree with active medical license valid in the state where research is conducted
- Board certification or board eligibility in a specialty appropriate to the research
- Minimum 2 years experience as a Clinical Research Investigator
- Training and certification in DMCR-required training and site Standard Operating Procedures (SOPs)
- Training and certification in Good Clinical Practice (GCP)
- Training in IATA (as part of DMCR-required training)
- Maintain current curriculum vitae and up-to-date medical licensure
- Proficient verbal and written communication skills in English
- Proficient bilingual (English/Spanish) communication skills
What We Do
DM Clinical Research is a multi-therapeutic network of clinical trial investigator sites headquartered in Houston, Texas. Founded in 2006, the company connects patients with trusted physicians to conduct cutting-edge research focused on quality and compassion, aiming to deliver advanced, preventative medicine to underserved communities. They operate a national network of dedicated research centers and physician-embedded sites throughout the United States.
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