Clinical - Principal Investigator

Tribe513 | The Onyx Group•Spartanburg, SC

13d•Onsite

About The Position

The Principal Investigator (PI) is a primary care provider with experience in overseeing specialty studies such as cardiometabolic and GI therapeutic areas. The PI oversees all aspects of clinical trial(s) conducted at Tribe Clinical Research. The PI is the leader of the team of individuals conducting clinical investigations and under whose immediate direction the drug is administered or dispensed to a subject. The PI is responsible for the scientific integrity of the study, ensuring participant safety, and adherence to regulatory guidelines in accordance with federal regulations and sponsoring agency policies and procedures. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job. A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task. This position requires excellent time management and communication skills and confidentiality. Requires sitting, standing, and walking associated with a normal clinical research / physician office environment. This position may require travel. A person may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens. This position requires adherence to Tribe Clinical Research’s Core Values as outlined: We are passionate about working for a GROWTH ORIENTED company. We exhibit a HUMBLE but CONFIDENT approach to work. We communicate what needs to be said RESPECTFULLY. We love serving others and WORKING TOGETHER for the greater good. We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.

Requirements

Maintain current and up-to-date licensure to practice and credentials.
Demonstrating the proper education, training, and experience to conduct clinical investigations.
Knowledge of clinical trial design and methodology.
Knowledge of regulatory requirements for clinical research (FDA regulations, ICH-GCP guidelines).
Ability to provide thorough documentation and effective communication.
Highly organized
Excellent verbal and written communication
Able to multi-task
Excellent time management and communication skills
Confidentiality

Responsibilities

Protect the rights and welfare of subjects.
Obtain a signed and dated informed consent from the subject or subject’s legal representative prior to initiating any study-related procedures.
Ensure initial and ongoing review by a duly constituted IRB.
Ability to assess subject compliance, responses to therapy and adverse events.
Ensure the proper use and storage of investigational agents.
Safeguard documentation of study-related procedures, processes, and events.
Maintain good communication with site operations.
Ensure that all research staff are informed about their trial-related duties and functions.
Possess a thorough understanding of the requirements of each protocol and that adequate resources are available.
Safeguard protocol compliance to defend against protocol deviations.
Ensure validity of the data reported to the sponsor.
Effective communication and collaboration with research sponsors, CROs, and research teams.