Principal Investigator

DM CLINICAL RESEARCH GROUP•Houston, TX

23h•Onsite

About The Position

The Principal Investigator is accountable for ensuring adherence to protocol requirements, protecting the rights and welfare of research subjects, assuring the integrity of subject-generated data, and directing research in accordance with federal and state regulations and guidance documents. The role assumes responsibility for clinical investigation protocols and requires a thorough understanding of each protocol and the resources needed to conduct it. The Principal Investigator manages subjects’ medical care, oversees study staff training, and ensures the validity of trial data and documentation of study-related procedures, processes, and events. The role also includes explaining study protocols and medical procedures, risks, benefits, and alternatives to patients; conducting consent discussions; and ensuring patients understand the study before consent is obtained. The Principal Investigator facilitates communication among patients, healthcare providers, and research staff.

Requirements

M.D. or D.O.
Active medical license valid in the state where the research is conducted.
At least 2 years of experience as a Clinical Research Investigator.
Board certification or board eligibility in a specialty appropriate to the research conducted at the site.
Training and certification in required DMCR training and Standard Operating Procedures (SOPs).
Training and certification in Good Clinical Practice (GCP).
Proficient verbal and written communication and comprehension skills in English.

Nice To Haves

Proficient verbal and written communication and comprehension skills in both English and Spanish.

Responsibilities

Complete DMCR-required training, including GCP and IATA.
Maintain working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
Maintain a current curriculum vitae and current licensure to practice.
Assume responsibility for the conduct of clinical investigation protocols and maintain a thorough understanding of each protocol.
Determine whether adequate resources are available to conduct research protocols.
Manage the medical care of subjects and protect their rights and welfare.
Ensure the validity of trial data reported to the sponsor.
Ensure documentation of study-related procedures, processes, and events.
Ensure proper use and storage of Investigational Products.
Attend 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.
Explain study protocols clearly and ensure patients understand them before obtaining consent.
Facilitate effective communication among patients, healthcare providers, and research staff.
Perform other matters as assigned by management.