Principal Investigator-Psychiatrist

CenExel•Garden Grove, CA

1d•Onsite

About The Position

The Principal Investigator (PI) is charged to conduct research studies per regulatory, scientific, and clinical requirements, especially informed consent and IRB, using Good Clinical Practices (GCPs) and strictly following the research protocol that generates independent, high quality, and reproducible results. The PI is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Additionally, the PI is responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with site personnel to assure research is conducted in accordance with federal regulations.

Requirements

Must be able to effectively communicate verbally and in writing.
Board Certified M.D. (Preferably in Psychiatry)
Three years experience conducting psychiatry clinical trial research as either a PI or Sub-Investigator or have other highly relevant experience.
Active DEA license or able to obtain one.

Responsibilities

Oversees the conduct of research in accordance with federal regulations, with ultimate responsibility for its quality performance.
Assures medical safety and appropriate clinical care for research study participants.
Supervises research staff.
Oversees the research team to help ensure ethical conduct in all aspects of the research process, including but not limited to the treatment of human participants, conflicts of interest, data acquisition, and management of staff.
Knowledge regarding ongoing and current research studies, research indications, and investigational compounds, with emphasis on patient safety, data collection, and protocol execution.
Attends sponsor training meetings and helps ensure all staff are trained per protocol.
Conducts all CenExel and study related training in a timely manner.
Oversees collection of study data, especially efficacy and safety data-SIGNATURE OVERSIGHT AND INVOLVEMENT.
Oversees patient recruitment and retention.
Reviews study data on a daily basis to help ensure quality study conduct.
Meets with sponsor and other entities (e.g., CROs, regulatory, vendors, etc.) representatives to discuss study conduct.
Maintains constant, professional communication (e.g., via remote meetings and emails) with entities outside research site that are involved in conducting research studies.
Maintains records and makes these available for sponsor monitoring, auditing, and government inspection.
Provides direct clinical research supervision of research staff, including Director of Clinical Operations, Director of Recruitment, all Sub-Investigators such as Raters and covering MD’s.
Available for on-call coverage as required.
Attends trial industry conferences and sponsor and other entity meetings to help obtain more studies at the site and procure research knowledge.
Reviews study protocols and provides feedback to the sponsor and other entities.
Provide medical coverage and oversight for all employees, subjects, and personnel in the clinic.
Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.